CORTSCR A~3.5 SELF-TAP L30 TAN
Report
- Report Number
- 8030965-2020-02281
- Event Type
- Malfunction
- Date Received
- March 25, 2020
- Report Date
- February 27, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- UDI-DI
- 07611819305625
- PMA / PMN Number
- K131186
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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, H4, H6- VISUAL INSPECTION CONFIRMED THAT THE INNER CAP WITH HOLDER AND SCREW IS RETAINED WITHIN THE OUTER TUBE DURING DISASSEMBLY. BASED ON THE INVESTIGATION IT MAY BE ASSUMED, THAT THE OCCURRED DEVIATION IS A RESULT OF AN IMPROPERLY ASSEMBLY DURING THE EXTERNAL PACKAGING AND STERILIZATION PROCESS AT SUPPLIER FRUEH VERPACKUNGSTECHNIK AG. AS PART OF THE COMPLAINT INVESTIGATION RELATED TO TUBES UNABLE TO DISASSEMBLE / SCREW COULD NOT BE REMOVED / PACKAGE COULD NOT BE OPENED / INNER TUBE WAS STUCK IN OUTER TUBE / INNER PART WITH THE SCREW OF THE STERILE TUBE GOT STUCK IN THE OUTER PART / INNER TUBE DID NO DEPLOY FROM OUTER TUBE (FAILURE MODES), PARTS WERE RETURNED AND INSPECTED BY SYNTHES GMBH. UPON EVALUATION SYNTHES GMBH DETERMINED THE COMPLAINTS WERE LIKELY DUE TO AN ASSEMBLY ERROR AT PACKAGING SUPPLIER FRÜH VERPACKUNGSTECHNIK AG. THE EVALUATION REQUIRED OPENING AND CLOSING THE TUBES, WHICH MADE FURTHER EVALUATION BY FRÜH VERPACKUNGSTECHNIK AG IMPOSSIBLE, THEREFORE FRÜH VERPACKUNGSTECHNIK AG PERFORMED A PRODUCTION REVIEW WHERE THEY STATED THAT NO ASSEMBLY ERROR OCCURRED. IT IS THE POSITION OF SYNTHES GMBH THAT THE COMPLAINT IS ATTRIBUTED TO THE ASSEMBLY PROCESS AT FRÜH VERPACKUNGSTECHNIK AG. HOWEVER, AS PART OF AN UNRELATED PRODUCT ISSUE FRÜH VERPACKUNGSTECHNIK AG INCORPORATED ADDITIONAL 100% MANUFACTURING CONTROLS (I.E. TORQUE LIMITERS) FOLLOWED BY 100% IN-PROCESS INSPECTION (I.E. GAUGES) TO ENSURE THE PRODUCTS WOULD BE ASSEMBLED CORRECTLY. THESE ADDITIONAL STEPS WERE DETERMINED TO BE SUFFICIENT FOR FRÜH VERPACKUNGSTECHNIK AG AND SYNTHES GMBH TO ELIMINATE THE ISSUES THAT LED TO PRODUCT COMPLAINTS RELATED TO UNABLE TO DISASSEMBLE / SCREW COULD NOT BE REMOVED / PACKAGE COULD NOT BE OPENED / INNER TUBE WAS STUCK IN OUTER TUBE / INNER PART WITH THE SCREW OF THE STERILE TUBE GOT STUCK IN THE OUTER PART / INNER TUBE DID NO DEPLOY FROM OUTER TUBE. IN CONCLUSION, THE MANUFACTURING CONTROLS AND IN-PROCESS INSPECTION WERE INTRODUCED ON 30TH JANUARY 2020 AND THEREFORE ANY COMPLAINTS RELATED THE FAILURE MODES MENTIONED ABOVE FOR PRODUCT MANUFACTURED PRIOR TO 30TH JANUARY 2020 WOULD NO LONGER OCCUR. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.200.030TS, LOT: 5L69636, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 16.AUGUST 2019, EXPIRY DATE: 01.AUGUST 2024 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN BALSTHAL . PART: 04.200.030, LOT: 5L60130, MANUFACTURING SITE: BALSTHAL, RELEASE TO WAREHOUSE DATE: 29.JULY 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.
ADDITIONAL PRODUCT CODE: HWC. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INNER PART WITH THE SCREW OF THE STERILE TUBE GOT STUCK IN THE OUTER PART. THERE WAS NO MEDICAL PROCEDURE OR DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS IS 7 OF 9 FOR REPORT (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343554 | CORTSCR A~3.5 SELF-TAP L30 TAN | PLATE,FIXATION,BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | 5L69636 | 07611819305625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CANCELLOUSSCR Ø4 L50/15 SST| CANCELLOUSSCR Ø4 L50/15 TI| CORTSCR 3.5 SELF-TAP L26 TAN| CORTSCR 3.5 SELF-TAP L26 TAN| CORTSCR 3.5 SELF-TAP L30 TAN| CORTSCR 3.5 SELF-TAP L40 TAN| LOCKSCR Ø3.5 SELF-TAP L38 TAN| LOCKSCR Ø3.5 SELF-TAP L44 TAN| LOCKSCR Ø3.5 SELF-TAP L50 TAN| LOCKSCR Ø3.5 SELF-TAP L50 TAN| LOCKSCR Ø3.5 SELF-TAP L50 TAN |