BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 170MM - STERILE

    MDR report key: 8737330 · Received June 26, 2019

    Report

    Report Number
    2939274-2019-58871
    Event Type
    Injury
    Date Received
    June 26, 2019
    Report Date
    May 31, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096548
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 13-JUL-2018, EXPIRATION DATE: 31-MAY-2028, PART NUMBER: 04.037.142S, 11MM/130 DEG TI CANN TFNA 170MM-STERILE, LOT NUMBER: H677513 (STERILE), LOT QUANTITY: 6 . 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 PARTS REVIEWED: 04.037.942.2, LOCK PRONG, 130 DEGREE TFNA, BP55, LOT NUMBER: L910473, LOT QUANTITY: 96, WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: H571504, LOT QUANTITY: 1,000. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. 04.037.912.3, TFNA LOCK DRIVE, BP58, LOT NUMBER: H665696, LOT QUANTITY: 80. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80, LOT NUMBER: H597571, LOT QUANTITY: 2,589 LBS. 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE WAS RECEIVED AT CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE DEVICE SHOWS DISCOLORATION. IT IS OBSERVED THAT THE LOCKING PRONG OF THE TFNA IS BROKEN. IT IS UNKNOWN WHEN THE PRONG OF THE LOCKING MECHANISM IS BROKEN. FUNCTIONAL TEST: FUNCTIONAL INSPECTION CANNOT BE PERFORMED AS THE POST OPERATION CONDITION CANNOT BE REPLICATED AT CQ. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THIS COMPLAINT IS CONFIRMED. THE REPORTED CONDITION OF THE LOCKING MECHANISM CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. DOCUMENT/ SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: VISUAL INSPECTION, AND DOCUMENT SPECIFICATION REVIEW OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE COMPLAINT IS CONFIRMED AS THE LOCKING PRONG HAS BROKEN, BUT THE REPORTED LOCKING MECHANISM CONDITION CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    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. UPDATED EVENT INFORMATION PROVIDED FOR REPORTING. 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 · 0

    07/15/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING MECHANISM IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL DID NOT LOCK THE UNKNOWN HELICAL BLADE IN PLACE AND THE HELICAL BLADE THEN ADVANCED MEDIALLY. THIS COULD HAVE BEEN CAUSED BY SURGEON ERROR DURING THE IMPLANT OR A FAILED LOCKING MECHANISM. THE IMPLANTS WERE REMOVED/EXPLANTED ON (B)(6) 2019. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: TITANIUM LOCKING SCREW (PART #: 458.940, LOT #: H499571, QUANTITY #: 1) . THIS COMPLAINT INVOLVES TWO (2) DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING MECHANISM IN THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL DID NOT LOCK THE UNKNOWN HELICAL BLADE IN PLACE AND THE HELICAL BLADE THEN ADVANCED MEDIALLY. THIS COULD HAVE BEEN CAUSED BY SURGEON ERROR DURING THE IMPLANT OR A FAILED LOCKING MECHANISM. THE IMPLANTS WERE REMOVED/EXPLANTED ON (B)(6) 2019. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT CAPTURES THE INTRA-OP EVENT, WHERE THE LOCKING MECHANISM DID NOT ENGAGE/FAILED DURING IMPLANTATION, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POST-OP EVENT THAT THE HELICAL BLADE PERFORATED THROUGH THE FEMORAL HEAD. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529166 11MM/130 DEG TI CANN TFNA 170MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.142S H677513 10886982096548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention