BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE/FIXED HAMMER 400 GRAMS

    MDR report key: 12210990 · Received July 22, 2021

    Report

    Report Number
    2939274-2021-04213
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Report Date
    June 23, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZY
    UDI-DI
    10886982067296
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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- THE HAMMER, 400 GRAM (P/N: 03.010.058, LOT #: 4820680) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION IT WAS FOUND THAT DEVICE WAS RECEIVED WITH BROKEN PIECES IN THE HANDLE. SEVERAL FRAGMENTS HAVE BEEN GENERATED. SOME OF THE BROKEN FRAGMENTS WERE NOT RETURNED. THE REMAINDER OF THE INSTRUMENT SHOWS SIGNIFICANT DENTS, WEAR MARKS AND IMPACT MARKS. THE COMPLAINT CONDITION IS CONFIRMED FOR THE HAMMER 400 GRAMS (P/N 03.010.058, LOT 4820680). WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT OVER 17 YEARS OF IMPACT FORCES HAS CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT =PART #: 03.010.058, SYNTHES LOT #: 4820680, SUPPLIER LOT #: N/A , RELEASE TO WAREHOUSE DATE: 08 DEC 2004, MANUFACTURED BY: BRANDYWINE, NO NCR'S GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW =REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH 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). 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. 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) 2021, THE PATIENT UNDERWENT A HUMERAL NAIL CASE. DURING THE PROCEDURE, THE SLIDE/FIXED HAMMER BROKE INTO MULTIPLE PIECES. NO PIECES REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR A HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107246 SLIDE/FIXED HAMMER 400 GRAMS HAMMER, SURGICAL FZY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.058 4820680 10886982067296

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAILS: HUMERAL| UNK - NAILS: HUMERAL