LOCKSCR Ø5 SELF-TAP L60 SST
Report
- Report Number
- 8030965-2020-00528
- Event Type
- Injury
- Date Received
- January 21, 2020
- Date of Event
- January 1, 2019
- Report Date
- January 13, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWC
- PMA / PMN Number
- K131186
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- 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. CODE 3191 USED TO CAPTURE BONE DISORDER, FRACTURE NONUNION AND SURGICAL INTERVENTION. 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.
PRODUCT COMPLAINT # (B)(4). 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. E1: REPORTERS STATE: (B)(6). H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 213.360, LOT: 9577604, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 22.JUL.2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. LOT 9577604 WAS MANUFACTURED FROM BLANK PART: 213.360.999, LOT: 7879216, MANUFACTURING SITE: MONUMENT. MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 18-MAR-2015, PART NUMBER: 213.360.999, 5.0MM SCREW BLANK 60MM 05.0 LOCKING SCREW W/3.5MM HEX, LOT NUMBER: 7879216, LOT QUANTITY: 929. TWENTY-ONE PIECES WERE SCRAPPED IN CELL AT OP # 50, TURN HEAD, AS SET-UP PIECES. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE TWENTY-ONE PIECES NOTED. COMPONENT PART(S) REVIEWED: PART NUMBER: 13023, 316LC*RI4.98, LOT NUMBER: 7092026, LOT QUANTITY: 4,495 LBS. PRODUCT TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF TESTS SUPPLIED BY CARPENTER DATED 12-NOV-2012 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 14-FEB-2020: DHR REVIEWED THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE LOCKING SCREW Ø5 SELF-TAPPING L60MM IS BROKEN APART AT THE CROSSOVER FROM THE SHAFT TO THE HEAD, BOTH FRAGMENTS WERE RETURNED FOR EVALUATION. THE UPPER PART OF THE SHAFT IS DAMAGED, MOST LIKELY CAUSED DURING THE EXTRACTION WITHOUT THE HEAD. OTHERWISE IS THE THREAD AND HEAD IN A GOOD CONDITION WITH SLIGHT WEAR MARKS. DIMENSIONAL INSPECTION: DIAMETER AT THE FRACTURE FACE , DEPTH OF THE BORE AT RECESS. DRAWING SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSION AND THE MATERIAL SPECIFICATION OF THE LOCKING SCREW. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 316L STAINLESS STEEL ACCORDING TO NORM ISO 5832-1 FOR SURGICAL IMPLANTS THE CORRECT MATERIAL WAS USED. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE RECEIVED LOCKING SCREW IS BROKEN APART. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED, THE SCREW WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. THE EXACT CAUSE OF THIS SCREW BREAKAGE CANNOT BE DEFINED AS THERE WAS NO INFORMATION PROVIDED IF THE SCREW BROKE IN SITU OR DURING EXTRACTION. BASED ON THE PROVIDED INFORMATION WE CAN ONLY ASSUME THAT A COMPLICATION DURING THE HEALING PROCESS, LIKE THE MENTIONED METABOLIC BONE DISEASE WITH THE RELATED NON UNION, DID LEAD A FATIGUE FAILURE OF THE SCREW, EITHER IN SITU OR DURING EXTRACTION AS THE SCREW WAS WEAKENED. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.
CONCOMITANT DEVICE INVESTIGATION REQUIREMENTS: 5.0MM LOCKING SCREWSELF-TAPPING 80MM (PRODUCT CODE: 213.380, LOT #: L528658, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: 7918910, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: L108563, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (PRODUCT CODE: 213.365, LOT #: 2161126, QUANTITY: 2), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (PRODUCT CODE: 213.355, LOT #: 9875351, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 40MM (PRODUCT CODE: 213.340, LOT #: L629099, QUANTITY: 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PRODUCT CODE: 214.836, LOT #: 9401022, QUANTITY: 1). THIS REPORT IS 2 OF 4 FOR (B)(4).
CONCOMITANT DEVICE REPORTED: 5.0MM LOCKING SCREWSELF-TAPPING 80MM (PRODUCT CODE: 213.380, LOT #: L528658, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: 7918910, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: L108563, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (PRODUCT CODE: 213.365, LOT #: 2161126, QUANTITY: 2), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (PRODUCT CODE: 213.355, LOT #: 9875351, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 40MM (PRODUCT CODE: 213.340, LOT #: L629099, QUANTITY: 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PRODUCT CODE: 214.836, LOT #: 9401022, QUANTITY: 1).
PRODUCT COMPLAINT # (B)(4). CONCOMITANT PRODUCTS. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; 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 NEW ZEALAND AS FOLLOWS:DISTAL PT HAS BROKEN ANOTHER LCP DISTAL FEMUR PLATE, 13 HOLE RIGHT LCP DF PLATE INCOMPLETE BREAK IN DISTAL THIRD OF THE SHAFT WITH PLASTIC DEFORMATION. PT IS THOUGHT TO HAVE METABOLIC BONE DISEASE WHICH LEAD TO A NON UNION. PREVIOUS REVISION DONE IN (B)(6) 2019. CONCOMITANT DEVICE REPORTED: UNK SCREWS: LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73062 | LOCKSCR Ø5 SELF-TAP L60 SST | SCREW, FIXATION, BONE | HWC | OBERDORF SYNTHES PRODUKTIONS GMBH | 9577604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CORTSCR Ø4.5 SELF-TAP L36 SST| CORTSCR Ø4.5 SELF-TAP L36 SST| LOCKSCR Ø5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L80 SST| LOCKSCR Ø5 SELF-TAP L80 SST |