RAPIDSORB RAPID ReSORBABLe CRANIAL CLAMP

Transcription

1 RAPIDSORB RAPID ReSORBABLe CRANIAL CLAMP Resorbable fixation of cranial bone flaps SURGICAL TeCHNIQUe

2 RAPIDSORB Rapid Resorbable CRANIAL CLAMP Indication DePuy Synthes Companies of Johnson & Johnson RAPIDSORB Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations. Easy preliminary fixation The shaft of the RAPIDSORB Rapid Resorbable Cranial Clamp includes a ratcheting mechanism with small increments. This feature allows preliminary placement of the top disk until final fixation is achieved. Contraindication The DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamps are not intended for use in the presence of: x Active or latent infection x Limited blood supply x Insufficient quantity or quality of bone Quick and safe application With the RAPIDSORB Rapid Resorbable Cranial Clamp, there is no need to drill or tap for screw/tack fixation. The application is an easy 3-step procedure in which the implant is positioned, then intermediately adjusted and finally fixated with the application forceps. Only one instrument is required. The instrument features a force-limiting mechanism that ensures appropriate compressive forces. Radiolucent The clamp provides interference-free diagnostic imaging. Resorbed in one year* The stability of the RAPIDSORB Rapid Resorbable Cranial Clamp is retained at least 8 weeks during the critical bone healing phase and is resorbed in approximately 1 year.* * Average strength retention data on file at DePuy Synthes Companies of Johnson & Johnson. DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique

3 RAPIDSORB Rapid Resorbable Application Device for RAPIDSORB Rapid Resorbable Cranial Clamp Force-limiting mechanism Ratcheting mechanism Cutting trigger The advantages are clear RAPIDSORB Rapid Resorbable Cranial Clamps allow quick placement of cranial bone flaps with one instrument. Flexible disks adapt to various bone thicknesses and can be conveniently placed anywhere around the kerf. Once placed, the clamps maintain appropriate fixation for approximately 8 weeks postoperatively during the critical bone healing phase. Radiolucent material allows interference free diagnostic imaging. Resorbable material means the surgical site can return to its native state. RAPIDSORB Rapid Resorbable Material x 85:15 poly (L-lactide-co-glycolide) x The material is resorbed in 2 stages: The polymer chains are split by hydrolysis and decompose into monomers, which are broken further into CO 2 and H 2 O and excreted. L-Lactide (85%) Glycolide (15%) RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique DePuy Synthes Companies 1

4 RAPIDSORB Rapid Resorbable Cranial Clamp 1 Place clamps With the cranial bone flap removed, position the cranial clamps equidistant around the opening. The bottom disk is to be between the dura and the skull. Note: A minimum of 3 cranial clamps is required for secure fixation of cranial bone flaps in pediatric patients. Depending on the patient, eg adult, and bone flap size, more fixation points are recommended. 2 Replace the cranial bone flap Replace the flap, ensuring the shafts of the cranial clamps remain vertical in the kerf. Pretension each clamp by pressing the top disk to the cranial surface. A 2-finger pinching technique is suggested. When using more than 3 clamps, tighten the clamps in a crisscross pattern. 2 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique

5 RAPIDSORB Rapid Resorbable Cranial Clamp 3 Engage application device Flip the ratcheting mechanism forward to engage. Place the application device over a clamp shaft and lower the instrument to the top disk. 4 Apply tension Squeeze the instrument handles to tension the cranial clamp. Note: If clamps were not pre-tensioned as described in step 2, the tensioning step may be repeated to fully fixate the clamp. RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique DePuy Synthes Companies 3

6 RAPIDSORB Cranial Clamp 5 Cut the stem While maintaining tension on the clamp, cut the stem by squeezing the cutting trigger. After cutting a stem, release the ratcheting mechanism on the instrument. Repeat steps 3 to 5 until all clamps have been secured. 6 Removal To re-enter the cranium postoperatively, use forceps to grasp the top disk of the clamp along the kerf. Release the disk by lifting and rotating it parallel to the kerf. Repeat this procedure with the remaining clamps. The bone flap can now be removed. Notes: RAPIDSORB Cranial Clamps are single-use only and must be discarded after removal. Use new clamps to reattach the cranial bone flap. The kerf must be perpendicular to the surface of the cranium for proper placement of the clamps. The clamps are not recommended for kerf widths less than 1.5 mm or greater than 4 mm. Clamps are not recommended for burr holes larger than 10 mm in diameter. 4 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique

7 WARNINGS AND PRECAUTIONS The DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamp provides fixation and is intended to aid in the alignment and stabilization of bone flaps. The device can break or bend as a result of stress or activity, which could cause failure of the device or the treatment. The surgeon is to be thoroughly familiar with the devices, the method of application, the instruments, and the surgical procedure. The surgeon must select a type or types of internal fixation appropriate for the treatment. 1. Improper selection, placement, positioning, and fixation of the devices can cause subsequent undesirable results. 2. Resorbable devices provide fixation and are NOT intended to replace normal healthy bone or withstand stress of full load bearing. 3. The devices are NOT to be heated by any means. 4. The devices can break or be damaged due to excessive activity or trauma. This could lead to failure of the implant construct, which could require additional surgery and device removal. 5. Discard and DO NOT USE previously opened or damaged devices. Use only devices that are packaged in unopened or undamaged packages. 6. DO NOT USE if there is loss of sterility of the device. 7. Store in a dry condition. DO NOT STORE ABOVE 49ºC OR 120ºF. The DePuy Synthes Companies RAPIDSORB Rapid Resorbable Cranial Clamp implants are sterilized by gamma irradiation. DO NOT RESTERILIZE. CONTENTS STERILE UNLESS INSIDE PACKAGE IS OPENED OR DAMAGED. RAPIDSORB Rapid Resorbable Cranial Clamp Surgical Technique DePuy Synthes Companies 5

8 ORDeRING INFORMATION Implant S Rapid Resorbable Cranial Clamp, 18 mm, sterile, 1/pkg Instrument Application Device for Resorbable Cranial Clamp Instrument Tray Resorbable Cranial Clamp Instrument Tray Assembly consists of: Lid Instrument Tray Insert Limited Warranty and Disclaimer: DePuy Synthes Companies products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. Not all products are currently available in all markets. Some devices listed in this Technique Guide may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Manufactured by (United States): Synthes USA Products, LLC 1302 Wrights Lane east West Chester, PA Telephone: (610) To order: (800) Fax: (610) Legal manufacturer (Canada): Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) DePuy Synthes All rights reserved. DSUS/MOC/1014/0140 3/15