BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE

    MDR report key: 8892991 · Received August 14, 2019

    Report

    Report Number
    2939274-2019-59816
    Event Type
    Injury
    Date Received
    August 14, 2019
    Report Date
    July 21, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982096166
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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. DEVICE HISTORY LOT : MANUFACTURING DATE: 01-DEC-2016, EXPIRATION DATE: 31-OCT-2026, PART NUMBER: 04.037.060S, 10MM/130 DEG TI CANN TFNA 400MM/RIGHT ¿ STERILE, LOT NUMBER: H242412 (STERILE). THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION 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, BP55, LOT NUMBER: L064143, PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: 9937552. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, NS062851 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED 23-MAR-2016 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58 LOT NUMBER: H204072 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET NS062925 REV D MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80 LOT NUMBER: H123944 CERTIFICATE OF ANALYSIS RECEIVED FROM METALWERKS PMD DATED 24-MAY-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 09-JUN-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITYAND 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.

    Additional Manufacturer Narrative · 1

    PATIENT ID: (B)(6). DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2018. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF THE BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) FEMORAL NAIL DUE TO DELAYED HEALING AND NONUNION. HARDWARE WAS IMPLANTED IN (B)(6) 2018. THE FRAGMENTS FROM THE BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) FEMORAL NAIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), LOCKING SCREW (PART 04.005.530, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688141 10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.037.060S H242412 10886982096166

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention