INSERTION HANDLE FOR SUPRAPATELLAR
Report
- Report Number
- 8030965-2019-68594
- Event Type
- Malfunction
- Date Received
- September 24, 2019
- Date of Event
- August 26, 2019
- Report Date
- August 27, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- JDS
- UDI-DI
- 07611819447936
- PMA / PMN Number
- K111667
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6 INVESTIGATION SUMMARY : INVESTIGATION SITE: CUSTOMER QUALITY (CQ) ZUCHWIL SELECTED FLOW(S): DEVICE INTERACTION/FUNCTIONAL AND DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE PROXIMAL END (WHERE THE NAIL GETS ATTACHED), THE ORIENTATING NOSE IS DAMAGED (BROKEN OFF PIECE) ON THE OUTSIDE DIAMETER (THIS DAMAGE IS NOT RELEVANT TO THE FUNCTION), THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. IN ADDITION, THE INSTRUMENT IS IN A USED (WITH SOME SCRATCHES AND DENTS) BUT OTHERWISE IN A GOOD CONDITION. FUNCTIONAL TEST: AN INTERNAL FUNCTIONAL TEST WITH THE RETURNED PARTS WAS PERFORMED. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE INSERT-HANDLE AND THE CONNECTION SCREWS COULD BE ATTACHED AND DETACHED TO THE NAIL AS INTENDED. DIMENSIONAL INSPECTION: AS THE INSTRUMENT IS FULLY FUNCTIONAL, THE COMPLAINT IS UNCONFIRMED AND NO FURTHER INVESTIGATION WILL BE DONE, AS DIMENSIONAL EVALUATION. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT 14-4638. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT 14-4638. FURTHERMORE, ALL PARTS WENT THROUGH A 100% FUNCTIONAL TEST, BEFORE THEY HAD LEFT THE PRODUCTION. SUMMARY: BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE STEPS, COULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. PLEASE REFER TO THE CURRENT TECHNIQUE GUIDE. SINCE THE REPORTED OCCURRENCE COULD NOT BE REPRODUCED, WE DETERMINE THIS COMPLAINT AS UNCONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT : PART: 03.010.440, LOT: 14-4638 , MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 01.OCTOBER 2014. DEVICE HISTORY REVIEW : AN NCR WAS GENERATED DURING PRODUCTION. IT WAS DETECTED THAT THE PACKAGING OF ONE PRODUCT WAS DAMAGED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE THE AFFECTED PRODUCT WAS DISPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THERE WAS AN ISSUE WITH LOOSENING THE CONNECTION SCREW ATTACHED TO THE MOST PROXIMAL END OF THE NAIL WHEN THE SURGEON WANTED TO DISSEMBLE THE PERCUTANEOUS INSTRUMENTATION (THE INSERTION HANDLE AND CONNECTION SCREW WITHIN THE HANDLE). THE SURGEON COULD NOT TURN THE SCREW AT ALL WHEN THE FIRST NAIL WAS IMPLANTED. HE THEN TOOK THE NAIL OUT WITH THE INSTRUMENTATION STILL CONNECTED TO INSPECT IT. WHEN VISUALIZED THE INSERTION HANDLE SEEMED TO BE 'CHIPPED' AND ONE (1) OF THE 'TEETH' THAT ENGAGES THE NAIL WAS BROKEN. ANOTHER NAIL WAS TRIED USING THE SAME INSTRUMENTATION, AS THERE IS NO OTHER INSERTION HANDLE ON THE SET OR IN THE STATE TO USE, (2 LOANSETS NATIONWIDE AND THE OTHER WAS IN (B)(6)). THE SAME ISSUE OCCURRED BUT THE SURGEON AND HIS ASSISTANT WERE ABLE TO DISCONNECT THE CONNECTION SCREW WITH A SEVER AMOUNT/EXCESSIVE FORCE. THE SURGEON USED THESE PLUS THE RESPECTIVE PROTECTION SLEEVE/DRILL SLEEVE THROUGH THE AIMING ARM FOR SCREW INSERTION AT THE PROXIMAL END OF THE NAIL. FOR THE DISTAL LOCKING ONLY THE 4.3 DRILL BIT WAS USED AND THE DEPTH GAUGE WITH THE T25 SCREWDRIVER FOR SCREW INSERTION. HE ALSO REVISED A DISTAL TIBIA PLATE IN THE SAME CASE BUT THAT WAS COMPLETELY DIFFERENT INSTRUMENTATION THAT DID NOT AFFECT THE TIBIAL NAIL. THE PATIENT OBTAINED AN INFECTION THE NEXT WEEK. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WHERE THE 1 X 5MM CANCELLOUS SCREW WAS REPLACED WITH ANOTHER 5MM CANCELLOUS SCREW 40 MM (04.015.530) AT THE PROXIMAL PORTION OF THE NAIL/TIBIA. HE THEN PERFORMED A WASHOUT. CONCOMITANT DEVICES: SCREWDRIVER: PART NUMBER: 03.010.092441 AIMING ARM: PART NUMBER: 03.010.441 PROTECTION SLEEVE: PART NUMBER: 03.010.438S LOT H830081.
THIS REPORT IS LINKED TO (B)(4).
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING A TIBIAL NAIL PROCEDURE WITH SYNTHES EXPERT TIBIAL NAIL WITH THE SYNTHES SUPRAPATELLAR INSTRUMENTATION. WHEN THE NAIL WAS CHOSEN (10 MM DIAMETER X 300MM LONG ETN) THE SCRUB NURSE ASSEMBLED THE INSERTION HANDLE AND CONNECTION SCREW ALONG WITH THE NAIL. IT WAS SECURELY FITTED ON WITH THE AIMING ARM LINED UP WITH THE PROTECTION SLEEVES AND PROXIMAL SCREW HOLES. ONCE THE NAIL WAS INSERTED, IT LOCKED PROXIMALLY TO PLACE AN END-CAP BEFORE LOCKING DISTALLY. WHEN HE TRIED TO REMOVE THE CONNECTION SCREW WITH THE BALL POINT 8MM SCREWDRIVER, HE WAS UNABLE TO TURN THE SCREW. BECAUSE OF THIS HE HAD TO REMOVE THIS NAIL ENTIRELY, TAKING OUT THE NAIL WITH THE INSERTION HANDLE STILL ATTACHED. HE THEN PROCEEDED TO USE A LONGER NAIL TO AVOID USING AN ENDCAP. THE SURGEON WAS ABLE TO UNSCREW THEN SCREW THE CONNECTION SCREW FOR BOTH NAILS WHEN OUTSIDE OF THE PATIENT. HE INSERTED THE NEW NAIL, LOCKED PROXIMALLY AND HAD THE SAME ISSUE WITH UNSCREWING THE CONNECTION SCREW. THE SURGEON DID MANAGE TO UNSCREW IT BUT STATED IT WAS ON THE VERGE OF BREAKING THE SCREWDRIVER. REVISION WAS PERFORMED FOR DISTAL TIBIA AND INSERTION OF SUPRAPATELLAR EXPERT TIBIAL NAIL. THERE WAS A SURGICAL DELAY OF ONE HOUR. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN PROTECTION SLEEVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 906623 | INSERTION HANDLE FOR SUPRAPATELLAR | NAIL, FIXATION, BONE | JDS | OBERDORF SYNTHES PRODUKTIONS GMBH | 14-4638 | 07611819447936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 03.010.441| OUTER PROTECTION SLEEVE 14.5 F/ETN F/SUP| SCRDRIVER-HEX W/SPHERIC-HEAD Ø8| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM| UNK - GUIDES/SLEEVES/AIMING: SLEEVE| UNK - SCREWDRIVERS |