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RAPIDSORB® INJECTABLE POLYMER SYSTEM (IPS)
IN-SERVICE PRESENTATION
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Drill and fill resorbable fixation.
• RAPIDSORB® Injectable Polymer System (IPS) is a novel fixation system featuring a cordless delivery device, selectable fastener length, rapid-shot functionality, and an easy to follow technique.
• RAPIDSORB IPS is an alternative to resorbable screws and is designed to complement the 1.5 mm RAPIDSORB Rapid Resorbable Fixation System.
• The handheld delivery device accepts sterile Fastener Cartridges, which are equivalent to a multi pack of screws. The RAPIDSORB IPS delivery device heats and delivers polymer to the implantation site, creating a fastener in-situ.
RAPIDSORB Injectable Polymer System (IPS)
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Polymer
• Same polymer used in RAPIDSORB System plates, sheets, meshes and screws
• Copolymer formed by combining L-lactide and glycolide
• 85% L-lactide – characterized by high strength and long degradation time
• 15% Glycolide –characterized by lower strength and more rapid degradation
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB System | Science
• The RAPIDSORB System polymer resorbs in a period of about 12 months by bulk hydrolysis
• In bulk hydrolysis the polymer is broken down into acids by water in the body
• These acids are eliminated through natural body metabolism in the form of CO2 and H2O
• The RAPIDSORB System retains approximately 85% of its initial bending strength after 8 weeks1
1. Average Strength Retention File USBIO07003.
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB System RAPIDSORB IPSThe RAPIDSORB Rapid Resorbable Fixation system is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
In addition, resorbable meshes, sheets, screws, and tacks may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, meshes, and sheets.
In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).
Indications*
*Refer to the package inserts for the full list of indications, contraindications, warnings and/or precautions.
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS is not intended for use in full load bearing applications. These devices are not intended for areas with active or latent infection, limited blood supply, or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
RAPIDSORB System RAPIDSORB IPS
These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The RAPIDSORB Rapid Resorbable System is not intended for areas with active or latent infection, or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
Contraindications*
*Refer to the package inserts for the full list of indications, contraindications, warnings and/or precautions.
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• When:• Craniosynostosis reconstruction,
reconstruction in midface or cranium (excluding upper and lower jaw)
• When temporary fixation is desired• When unrestricted bone growth is required
• Why:• Resorbs in approximately 12 months• Radiolucent material does not interfere with
radiographic imaging • Provides sufficient strength during initial
healing phase
RAPIDSORB IPS | Applications
CraniosynostosisReconstruction /
Cranial Vault Remodeling
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
FEATURES & BENEFITS
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Features & Benefits
• Reduces hand-offs for reloading• No picking up screws or pins • Produce approximately 20 fasteners at 4 mm length
with large Fastener Cartridge
Fastener Cartridge
• Reduces carrying fastener inventory• Less hand-offs in surgery• Adjust fastener length by Fastener Length Dial – no
need to open another pack of screws or pins
Adjustable lengths on demand
• No cords or foot pedalBattery-Operated
• Proven polymer (85:15 poly (L-lactide-co-glycolide) with low inflammatory response
• RAPIDSORB System polymer has been on the market since 2003
Proven Polymer
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
SYSTEM OVERVIEW
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• All visible parts are provided sterile and are disposable
RAPIDSORB IPS | Delivery Device
Device Tip
Fastener Cartridge Port
Push Rod Release Lever Push Rod
Fastener Length Dial
Battery Pack
Activation Button
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• The back of the device contains icons and symbols that illuminate on the back of the device that notifies the user if the device requires attention.
RAPIDSORB IPS | Icons on Back of Device
Standby
Ready
Heating
Caution/Fault
Low Battery
Low Polymer
Fastener Length Fastener Length Dial
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Disposable Components
Delivery Device Starter Kit
Battery Pack Fastener Cartridge
Drill Bits Replacement Cap
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• RAPIDSORB IPS Delivery Device Starter Kit contains• Device Shell • Device Cap• Starter Fastener Cartridge –
produces approximately 15 fasteners at 4 mm length
• Reference Card
RAPIDSORB IPS | Delivery Device Starter Kit
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• Doubled-sided card to aid in device assembly and priming
• Sterile packed in each Starter Kit
RAPIDSORB IPS | Reference Card
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Battery Pack - Sterile
• Single-use lithium battery specific to RAPIDSORB IPS
• Important: • To maximize battery life, RAPIDSORB IPS should be
assembled and powered up about 15 minutes prior to its use.
• Alternatively, RAPIDSORB IPS can be assembled and primed at the start of the case then the battery removed to conserve battery life. About 5 minutes before use the Battery Pack should be inserted and warmed to its Ready state.
• Battery Packs must ship via ground. Please plan accordingly. Battery Packs have 5 year shelf life.
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Small Fastener Cartridge
• Approximately 5 fasteners at 4 mm length
• 805.505.01S
Medium Fastener Cartridge
• Approximately 10 fasteners at 4 mm length
• 805.510.01S
Large Fastener Cartridge
• Approximately 20 fasteners at 4 mm length
• 805.520.01S
RAPIDSORB IPS | Fastener Cartridges
• All fastener cartridges appear the same, but contain different amounts of polymer
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB System Temperature Dot RAPIDSORB IPS Temperature Dot
RAPIDSORB IPS | Temperature Sensitive
New temperature dots trigger at a lower temperature, 104F (40C).
IF TEMPERATURE INDICATOR IS BLACK
DO NOT USE
Product okay to use
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• Specific to RAPIDSORB IPS, 1.7 mm diameter• Provided sterile• 3 mm – 8 mm
RAPIDSORB IPS | Drill Bits
310.403S 1.7 mm Drill bit w/ 3 mm stop, J-latch for RAPIDSORB IPS – Sterile
310.404S 1.7 mm Drill bit w/ 4 mm stop, J-latch for RAPIDSORB IPS – Sterile
310.405S 1.7 mm Drill bit w/ 5 mm stop, J-latch for RAPIDSORB IPS – Sterile
310.406S 1.7 mm Drill bit w/ 6 mm stop, J-latch for RAPIDSORB IPS – Sterile
310.407S 1.7 mm Drill bit w/ 7 mm stop, J-latch for RAPIDSORB IPS – Sterile
310.408S 1.7 mm Drill bit w/ 8 mm stop, J-latch for RAPIDSORB IPS - Sterile
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• A Replacement Cap is also available • To be used if cap sterility is compromised during device assembly• Replace cap without having to open a new RAPIDSORB IPS Delivery
Device Starter Kit
RAPIDSORB IPS | Replacement Cap
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Non‐sterile
Power Drive Unit
Sterility Shield (Remove before applying cap)
Sterility Shield
Power Drive Unit
RAPIDSORB IPS | Non-Disposable Components
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• Used to insert non-sterile Power Drive Unit into Delivery Device Shell
• Sterilized after each case• Ensure Sterility Shield is not
thrown away or lost • Etched with RAPIDSORB IPS• A backup Sterility Shield should
always be available for cases in the event that the Power Drive Unit needs to be replaced
RAPIDSORB IPS | Sterility Shield
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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• Software-enabled • DO NOT STERILIZE• At the end of the case:
• Wiped down • Placed back in Power Drive
Unit Case• Ensure unit is not throw away
at the end of the case!• 1 year maintenance schedule
RAPIDSORB IPS | Power Drive Unit
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS For each case:
*A backup Power Drive Unit, Sterility Shield and Delivery Device Starter Kit should be available for all procedures.
Power Drive Unit*
Sterility Shield
Disposable items
Delivery Device Starter Kit*
Battery Pack (sterile)
RAPIDSORB IPS Drill Bit
Fastener Cartridge
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
TECHNIQUE OVERVIEW
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RAPIDSORB IPS DELIVERY DEVICERAPIDSORB IPS DELIVERY DEVICE
Please see the RAPIDSORB Injectable Polymer System (IPS) Technique Guide (DSUS/BIO/0516/0092) for all technique information.
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In preparation for fixating RAPIDSORB System plates, meshes, or sheets using RAPIDSORB IPS, preoperative assembly is required. To prevent contamination during assembly, a sterile (scrubbed) person and a non-sterile (circulating) person are required. All steps are completed by the sterile (scrubbed) person unless otherwise noted.
What you need to assemble RAPIDSORB IPS:805.550.01S RAPIDSORB IPS Delivery Device Starter Kit - Sterile530.551 RAPIDSORB IPS Power Drive Unit530.553.01S RAPIDSORB IPS Battery Pack – Sterile530.554 RAPIDSORB IPS Sterility Shield
ASSEMBLYASSEMBLY
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Press Push Rod Forward until it stops
Push Rod
1 32Position
Sterility Shield over opening
Circulating Person –Insert Power Drive
Unit by aligning orange indicators
ASSEMBLY INSTRUCTIONSASSEMBLY INSTRUCTIONS
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Place Cap over Power Drive
Unit
4Turn Cap
clockwise to lock position
5Insert
Battery Pack
6
Icons light up on back
of the device.
Device is in Standby.
ASSEMBLY INSTRUCTIONS (continued)ASSEMBLY INSTRUCTIONS (continued)
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Press Release Lever forward and pull back
Push Rod until etched ring is
visible
1Insert tip of Fastener
Cartridge into Fastener Cartridge Port and push
ribbed portion of Fastener Cartridge forward until
polymer is transferred into the device
2
Discard empty Fastener Cartridge.
Advance the Push Rod until
it stops
3
LOAD FASTENER CARTRIDGELOAD FASTENER CARTRIDGE
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The quantity of fasteners produced will vary depending on length of fasteners being implanted. The fastener length can be adjusted with the Fastener Length Dial on the device Cap. See the table below for approximate quantities.
Note: If reloading the device with additional Fastener Cartridges, please table on page 15 of the RAPIDSORB IPS Technique Guide (DSUS/BIO/0516/0092) for fastener quantities.
STARTER CARTRIDGE FASTENER PRODUCTIONSTARTER CARTRIDGE FASTENER PRODUCTION
Approx. Quantity of Fasteners Produced By Starter Cartridge* After Device is Primed
Fastener Length 3 mm 4 mm** 5 mm 6 mm 7 mm 8 mm
Approx. Quantity of Fasteners 17 15 12 11 9 8*Starter Cartridge is included in the RAPIDSORB IPS Delivery Device Starter Kit**4 mm is the most common length
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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INTRAOPERATIVE POLYMER RELOADINGINTRAOPERATIVE POLYMER RELOADING
Approx. Quantity* of Fasteners Produced By Fastener Cartridges When Reloading
Fastener Length 3 mm 4 mm** 5 mm 6 mm 7 mm 8 mm
805.505.01S – Small FastenerCartridge
5 5 4 3 3 2
805.510.01S – Medium Fastener Cartridge
12 10 8 7 6 6
805.520.01S – Large Fastener Cartridge
25 21 18 15 13 12
*The quantities are accurate when reloading a device that has previously been used to insert fasteners**4 mm is the most common length
Additional Fastener Cartridges may be added to refill the device with polymer if required to complete the procedure. The Low Polymer icon will be illuminated to indicate when additional polymer is needed. See table below for guidance on choosing Fastener Cartridge size according length and quantity of fasteners required.
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• Press and release Activation Button to bring device out of Standby and start heating
• Ready Icon will illuminate when device is up to temperature
Heat Device
• Press and release Activation Button to start fastener formation cycle
• Repeat until polymer is expelled from the tip
Press Activation Button
• Remove excess polymer with sterile gloved fingertips and discard
• Caution: Avoid prolonged contact with the tip, as surface temperature may reach 100C
Remove excess polymer
PRIME DEVICEPRIME DEVICE
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• Drill bit perpendicular to bone• Irrigation is recommended• Do not damage plate
• An optional bolus of polymer can be created on the underside of the bone by selecting a longer length fastener.
• Hold device perpendicular
• Press Activation Button• Remove device after Ready
icon blinks 4 times
Drill hole through plate
Choose Fastener length
Align tip through plate and into hole
Insert Fastener
TECHNIQUE OVERVIEWTECHNIQUE OVERVIEW
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FORMING FASTENERSFORMING FASTENERS
Optional bolus examples:
3 mm Fastener Length in 2 mm
bone
4 mm Fastener Length in 2 mm
bone
4 mm Fastener Length in 4 mm
bone
5 mm Fastener Length in 4 mm
bone
6 mm Fastener Length in 4 mm
bone
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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FASTENER TROUBLESHOOTINGDescription Remedy
Normal Head N/A
Inadequate pressure Hold against plate with more force (use light pressure against plate)
Early pull-off Wait for the “READY” icon to flash 4 times before pulling off
Too much pressure Hold against plate with less force (use light pressure against plate)
Lateral movement Hold device steady and axially in line with hole during formation
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS Technique Tips!
• To maximize battery life, RAPIDSORB IPS should be assembled and powered up about 15 minutes prior to its use. It can also be assembled at the start of the case and then the Battery Pack removed to conserve battery.
• If icons on the back of the device do not illuminate when the battery is inserted, be sure that the cap is fully locked (turn clockwise).
Maximize Battery Life
• Only insert a new Fastener Cartridge if the Low Polymer Icon is illuminated.• Be certain that the Push Rod is fully pulled back and etched ring is visible before
adding polymer.• Be careful not to push the Activation Button during reloading process.• Ensure Fastener Cartridge is fully collapsed after loading polymer.
Loading Fastener Cartridges
• Apply light pressure so that the tip of the device does not lift from the plate• The Ready Icon indicates when the fastener formation cycle is complete. The
Ready Icon will blink 4 times and will then remain on when the fastener has been formed.
Fastener Insertion
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
STUDY RESULTS
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Animal Study Results
• Sheep study• No evidence of thermal
necrosis • Demonstrated comparable
biocompatibility, irritancy scores and healing in comparison to the RAPIDSORB Rapid Resorbable Fixation System and KLS Martin’s SonicWeld Rx System
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Shear Strength Data
0
20
40
60
80
100
120
140
160
0 Wk 2 Wk 4 Wk 8 Wk 12 Wk
New
tons
(N)
Shear Strength ComparisonInvitro Test Data
1.5mm RAPIDSORB IPS Fasteners 8mm – Sterile 1.5 x 6mm Direct Drive Lactosorb Screws-Sterile
1.5mm RAPIDSORB System Screws 8mm-Sterile 1.6 x 6mm KLS Martin Resorb x SonicPins RX -Sterile
ReferenceMechanical Test Lab TestMT13-072 and MT13-155
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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RAPIDSORB IPS | Axial Pullout Data
0
10
20
30
40
50
60
70
0 Wk 2 Wk 4 Wk 8 Wk 12 Wk
New
tons
(N)
Axial PulloutInvitro Test Data
1.5mm RAPIDSORB IPS Fasteners 4mm-Sterile 1.5 x 3mm Direct Drive Lactosorb Screw-Sterile
1.5mm RAPIDSORB System Screw 4mm-Sterile KLS Martin Resorb x SonicPins RX 1.6 x 4 mm Sterile
Reference:Mechanical Test Lab TestMT13-071 and MT13-156
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Time Study Results | Time to Insert a Fastener/Pin/Screw
0 5 10 15 20 25 30 35 40
RAPIDSORB IPS
RAPIDSORB System
LactoSorb
SonicWeld Rx
Seconds/ Successful Fastener
Average Tef
Results show that the Tef for the RAPIDSORB IPS and SonicWeld were comparable (a difference of 0.71 seconds per successful fastener), and the times for those two systems being about half that of the LactoSorb and RAPIDSORB System.
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Time Study Results | Average Procedure Times – 20 Fasteners/Pins/Screws
0.00 100.00 200.00 300.00 400.00 500.00 600.00 700.00 800.00 900.00Seconds
Average Overall Time
LactoSorbSonicWeld RxRAPIDSORB SystemRAPIDSORB IPS
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Time Study Results – Less Product Waste
System Replaced Fasteners
Adjusted Fasteners
RAPIDSORB IPS 0 N/ARAPIDSORB System 7 1
LactoSorb 14 12SonicWeld Rx 10 12
• Fasteners are considered replaced fasteners if the original fastener that was used to fix the plate was damaged in a way that the old fastener needed to be drilled out and an emergency kit needed to be utilized.
• Overall the LactoSorb system experienced the highest amount of replaced fasteners across all participants (n=14), while none of the RAPIDSORB IPS fasteners needed to be replaced.
• Overall the LactoSorb and SonicWeld Rx systems experienced the highest amount of adjusted fasteners across all participants (n=12), while RAPIDSORB System only needed 1 fastener to be adjusted.
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Time Study Results – NASA Task Load Index
0
20
40
60
80
100
Mental Demand Phyiscal Demand Temporal Demand Performance Effort Frustration
RAPIDSORB IPS SonicWeld Rx RAPIDSORB System LactoSorb
Mental Demand - How mentally demanding was the task?Physical Demand - How physically demanding was the task?Temporal Demand - How hurried or rushed was the pace of the task?Performance - How successful were you in accomplishing what you were asked to do?Effort - How hard did you have to work to accomplish your level of performance?
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
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Time Study Results – NASA Average Workload
0
20
40
60
80
100
Overall Workload
RAPIDSORB IPS SonicWeld Rx RAPIDSORB System LactoSorb
**
*
*
*
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
QUESTIONS?
DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.
The third party trademarks used herein are the trademarks of their respective owners.