BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/125 DEG TI CANN TFNA 200MM - STERILE

    MDR report key: 10015317 · Received April 30, 2020

    Report

    Report Number
    8030965-2020-03228
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: DECEMBER 17, 2015, EXPIRATION DATE: NOVEMBER 1, 2025, PART NUMBER: 04.037.113S, 11MM/125 DEG TI CANN TFNA 200MM- STERILE, LOT NUMBER: 9953476 (STERILE), LOT QUANTITY: 6. 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 LPPF, LMD/LPF 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: 04.037.912.2, LOCK PRONG, 125 DEGREE, TFNA, BP55, LOT NUMBER: 9708094, LOT QUANTITY: 96. PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: 9850942, LOT QUANTITY: 1,000. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED OCTOBER 16, 2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58, LOT NUMBER: 9948671, LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80, LOT NUMBER: 7552482, LOT QUANTITY: 994 LBS. CERTIFICATE OF ANALYSIS SUPPLIED BY METALWERKS PMD INC. DATED DECEMBER 9, 2014 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 09-DEC-2013 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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. VISUAL INSPECTION: THE RECEIVED TFNA FEMORAL NAIL 11MM HAS SHOWN THAT WEAR MARKS AT THE CONNECTION PART AS WELL AS THE LOCKING MECHANISM OF THE TFNA BLADE VISIBLE. FURTHER INVESTIGATION HAS SHOWN THAT THE NOSE TIP OF LOCKING MECHANISM IS SLIGHTLY DEFORMED. FUNCTIONAL TEST: A FUNCTIONAL TEST WITH THE RETURNED TFNA NAIL AND A DEMO TFNA BLADE WAS PERFORMED. THE COMPLAINED MALFUNCTION OF "THE LOCKING MECHANISM DIDN¿T WORK" COULD NOT BE REPLICATED. THE RETURNED NAIL / LOCKING MECHANISM PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE LOCKING MECHANISM OF THE NAIL IS FULL FUNCTIONAL AS INTENDED. NO INTERFERING COULD BE DETECTED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. DIMENSIONAL INSPECTION: AS THIS INVESTIGATION IS FOCUSED IN THE FUNCTIONAL ISSUE AND THIS WAS COVERED THROUGH THE FUNCTIONAL TEST PERFORMED. THEREFORE, NO MEASUREMENTS OF THE FEATURES ARE REQUIRED. SUMMARY: THE COMPLAINT IS RATED AS UNCONFIRMED FOR THIS RETURNED TFNA NAIL BECAUSE THE COMPLAINED MALFUNCTION COULD NOT BE REPLICATED. THE RETURNED TFNA NAIL PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE LOCKING MECHANISM OF THE NAIL IS FULL FUNCTIONAL AS INTENDED. NO INTERFERING COULD BE DETECTED. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. BASED ON OUR INVESTIGATIONS, WE ONLY CAN ASSUME THAT THE SLIGHTLY DEFORMED NOSE OF LOCKING MECHANISM WAS DAMAGED BY INADEQUATE HANDLING DURING THE INSERTION. POSSIBLY AN INSUFFICIENT CONNECTION, WRONG ANGULATION DIRECTION WHICH FINALLY CAUSED THE SLIGHTLY DAMAGE OF THE LOCKING MECHANISM IN THE TFNA NAIL. NEVERTHELESS, THE LOCKING MECHANISM OF THE NAIL IS FULL FUNCTIONAL AS INTENDED. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED HANDLING FAULT AT THE DEVICES. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL FEMORAL TROCHANTERIC FRACTURES BY USING THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. DURING THE SURGERY, WHILE INSERTING THE NAIL, THE LOCKING MECHANISM OF THE NAIL WOULD NOT ADVANCE. ANOTHER NAIL WAS USED AND THE INSERTION WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. CONCOMITANT DEVICE: CANNULATED CONNECTING SCREW (PART# 03.037.010, LOT# 9667929, QUANTITY 1) T-HANDLE BALL HEXAGONAL SCREWDRIVER (PART# 03.010.517, LOT# 9642328, QUANTITY 1) CANNULATED CONNECTING SCREW (PART# 03.037.010, LOT# 9667930, QUANTITY 1) THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 200MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479034 11MM/125 DEG TI CANN TFNA 200MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9953476

    Patients

    Seq Age Sex Outcome Treatment
    1 CONNECSCR F/INSERTION HANDLE| CONNECSCR F/INSERTION HANDLE| SCRDRIVER-HEX Ø8 W/T-HANDLE W/SPHERIC-HE