11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE
Report
- Report Number
- 8030965-2020-05349
- Event Type
- Injury
- Date Received
- July 28, 2020
- Report Date
- June 27, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- PMA / PMN Number
- K131548
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
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. D7: DATE OF EXPLANTATION IS AN UNKNOWN DATE IN (B)(6) 2020. H4, H6: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: MARCH 12, 2019, EXPIRATION DATE: MARCH 01, 2029, PART: 04.037.157S, 11MM/130 DEG TI CANN TFNA 360MM/LEFT- STERILE, LOT: H843365 (STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. STERILIZATION CONTROL NUMBER (SCN) SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, LOT: 2L97700, PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 04.037.912.4, WAVE SPRING, SHIM ENDED LOT: H681026. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART: 04.037.912.3, TFNA LOCK DRIVE LOT: H820893. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART: 21127, TIMOAGRI16.00 LOT: H823170. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS INC. WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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.
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. INVESTIGATION FLOW: FUNCTIONAL/ VISUAL, TFNA HELICAL BLADE PERF L105 TAN (P/N: 04.038.405S, LOT NUMBER: H831247). VISUAL INSPECTION: THE TFNA FEM NAIL 11 LE 130° L360 TIMO15 (P/N: 04.037.157S, LOT NUMBER: H843365, QTY# 1) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THERE WERE FEW SCRATCHES AND DISCOLORED SPOTS ALL OVER THE SURFACE OF THE BODY. THE SCRATCHES MIGHT BE DUE TO EXPLANTATION PROCEDURE. DRILL MARKS WERE OBSERVED ON THE HELICAL SCREW HOLE. THE LOCK PRONG WAS POPPED OUT FROM ITS ORIGINAL POSITION. THE DEVICE FAILURE/ DEFECT WAS FOUND. FUNCTIONAL TESTING: FUNCTIONAL TESTING OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE HELICAL BLADE (TFNA HELICAL BLADE PERF L105 TAN P/N: 04.038.405S, LOT NUMBER: H831247) WAS NOT LOCKING WITH THE RECEIVED DEVICE AS INTENDED. THE LOCK PRONG OF THE TFNA IS NOT SCREWING IN AND LOCKING THE HELICAL BLADE PROPERLY. THUS, THE REPORTED LOCK/ UNLOCK CONDITION IS BEING CONFIRMED. THE HELICAL BLADE IS BEING INVESTIGATED IN PI-(B)(4) UNDER SAME COMPLAINT. THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AS THE RELEVANT DIMENSIONS ARE INACCESSIBLE DUE TO THE RECEIVED CONDITION OF THE DEVICE. DOCUMENTATION/ SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR TFNA FEM NAIL 11 LE 130° L360 TIMO15 (P/N: 04.037.157S, LOT NUMBER: H843365) AS THE LOCK PRONG OF THE TFNA IS NOT SCREWING IN AND LOCKING THE HELICAL BLADE PROPERLY. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. PIE/ PIA WAS LAUNCHED PREVIOUS TO THIS COMPLAINT TO INVESTIGATE TFNA NAIL BREAKAGE AND ASSOCIATED DRILL MARKS/DAMAGE AT THE HEAD ELEMENT HOLE/BLADE APERTURE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 12-MAR-2019, EXPIRATION DATE: 01-MAR-2029, PART NUMBER: 04.037.157S, 11MM/130 DEG TI CANN TFNA 360MM/LEFT- STERILE, LOT NUMBER: H843365 (STERILE), LOT QUANTITY: 6 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL NS MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION NS MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 16089 SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA , LOT NUMBER: 2L97700, LOT QUANTITY: 95 . PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, LOT NUMBER: H681026, LOT QUANTITY: 1,000. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED 02-OCT 02, 2018 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, LOT NUMBER: H820893, LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, NS062925 REV E MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, LOT NUMBER: H823170, LOT QUANTITY: 2,731 LBS. CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS INC. DATED DEC 20, 2018 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED JAN 23, 2019 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY REVIEW . JUL 29, 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. 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.
UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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 ON AN UNKNOWN DATE THAT THERE WAS AN ADVERSE OUTCOME USING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AND SPIRAL BLADE. THE SET SCREW MAY NOT HAVE BEEN FULLY EMPLOYED TO ENGAGE THE SPIRAL SCREW. FOLLOWING THE TFNA IMPLANTATION USING A HELICAL BLADE, THE PATIENT WAS DISCHARGED AND WAS WEIGHT BEARING. SHE SUBSEQUENTLY COMPLAINED OF INCREASING PAIN AND UPON FURTHER X-RAYS THE HELICAL BLADE HAD MIGRATED MEDIALLY. THE TFNA AND BLADE WERE REMOVED AND REPLACED WITH A NEW TFNA NAIL, LAG SCREW AND LCP PROXIMAL FEMORAL HOOK PLATE IN (B)(6) 2020. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797518 | 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | H843365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | TFNA FEM NAIL Ø11 LE 130° L360 TIMO15| UNK - END CAPS: TFNA| UNK - SCREWS: LOCKING |