HANDLE MINI-QUICK-COUPL
Report
- Report Number
- 8030965-2020-02873
- Event Type
- Malfunction
- Date Received
- April 16, 2020
- Report Date
- March 23, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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, H6: PART: 310.950, LOT: 8971978, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: JULY 22, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF THE COMPLAINT INVESTIGATION A FUNCTIONAL TEST FOR THE FEMALE COUPLING OF THE DEVICE WAS PERFORMED. FOR THE FEMALE COUPLING FEATURE THE FUNCTIONAL TEST WAS PERFORMED WITH FUNCTIONAL GAUGE. THE SLEEVE WAS PUSHED BACK BY HAND TO INSERT THE FUNCTIONAL GAUGE AND AUTOMATICALLY RETURNED TO THE "CLOSED" POSITION WHEN THE FUNCTIONAL GAUGE ARRIVED AT THE FINAL POSITION. THE RETURNED DEVICE WAS NOT ABLE TO HOLD THE GAUGE TIGHT IN ITS CLOSED POSITION AND THE GAUGE WAS REMOVABLE WITHOUT PUSHING BACK THE SLEEVE AGAIN. THE RETURNED DEVICE DID NOT PASS THE FUNCTIONAL TEST, THEREFORE THE COMPLAINT IS RATED AS CONFIRMED. REGARDING THE DHR, THE SAME FUNCTIONAL TEST WAS PERFORMED DURING THE ASSEMBLY OF THE ARTICLE. THE ASSEMBLY WAS INSPECTED 100% AND DOCUMENTED IN THE INSPECTION SHEET. AFTER THE FIRST FUNCTIONAL TEST, THE DEVICE WAS DISASSEMBLED AND FOUND AN ISSUE WAS DETECTED. IT WAS NOTICED THAT THE HOLDING BALL (POS. 8) HAD BROWN/YELLOWISH STAINS ON ITS SURFACE. THE RESIDUES AT POS. 8 INDICATE THAT THE HANDLE HAS BEEN IMPROPERLY REPROCESSED AND LUBRICATED BY THE CUSTOMER. AND IT SEEMS THAT THIS DETAIL CAN HAVE AN INCIDENCE ON THE ISSUE WITH THE FUNCTIONALITY AS REPORTED BY THE CUSTOMER. AFTER REASSEMBLING THE HANDLE, IT HAS BEEN SHOWN THAT THE DEVICE WORKS AS INTENDED EVEN AFTER SEVERAL TESTS. FOR THIS REASON, WE CAN FINALLY CONCLUDE THAT THE COMPLAINT IS NOT CONFIRMED FROM THE MANUFACTURING POINT OF VIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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.
THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 BEFORE A SURGERY THE SURGEON WAS UNABLE TO ATTACH A SCREWDRIVER SHAFT TO THE HANDLE. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVERS: SHAFTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HANDLE MINI-QUICK-COUPL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432478 | HANDLE MINI-QUICK-COUPL | TAP,BONE | HWX | OBERDORF SYNTHES PRODUKTIONS GMBH | 8971978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK - SCREWDRIVERS: SHAFTS |