BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 11247511 · Received January 28, 2021

    Report

    Report Number
    2939274-2021-00538
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Report Date
    January 8, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188373
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PRODUCT CODE: 314.020, LOT NUMBER#: 2140972, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 07. JUNE 2005. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, FOR THE FINISHED DEVICE LOT NUMBER. AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SCREWDRIVER HEX-SMALL W/HOLD-SLEEVE (PART NO: 314.020, LOT#: 2140972), WAS RECEIVED AT US CUSTOMER QUALITY (CQ), WEST CHESTER. UPON RECEIVING THE DEVICE, THE TIP OF THE DEVICE WAS OBSERVED TO BE DEFORMED. THE DEVICE IS ALSO, MISSING THE HOLDING SLEEVE. ADDITIONALLY, SCRATCHES, RUST MARKS AND ETCH MARKINGS WERE OBSERVED ON THE DEVICE. NO OTHER ISSUES WERE OBSERVED. DEVICE FAILURE/ DEFECT IDENTIFIED? YES, THE TIP OF THE RETURNED DEVICE WAS DEFORMED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED, DUE TO POST-MANUFACTURING DAMAGE. DOCUMENTATION/SPECIFICATION REVIEW: THE FOLLOWING DOCUMENT WAS REVIEWED: SMALL HEX SCREWDRIVER W/HOLD-SLEEVE: MANUFACTURED AND CURRENT. NO DISCREPANCIES WERE OBSERVED, IN THE DESIGN OF THE DEVICE. COMPLAINT CONFIRMED: YES, THE COMPLAINT COULD BE CONFIRMED, AS THE TIP OF THE DEVICE WAS DEFORMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION FOR SCREWDRIVER HEX-SMALL W/HOLD-SLEEVE (PART NO: 314.020; LOT#: 2140972), WAS RECEIVED WITH A BROKEN HANDLE. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE DEVICE COULD HAVE ENCOUNTERED UNINTENDED FORCES, WHICH COULD HAVE LED TO THE COMPLAINT CONDITION. 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. 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 · 1

    REPORTER IS JNJ REPRESENTATIVE. THE DEVICE WAS 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, DURING INSPECTION, IT WAS FOUND OUT THAT THE HEXAGONAL SCREWDRIVER LOSING ITS HEXAGONAL SHAPE, THE COLUMN VOLAR DISTAL RADIUS PLATE, AND LCP DÍA-META VOLAR DISTAL RADIUS PLATE WERE CHIPPING OF MOD HANDLE AND LID. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT INVOLVES ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144870 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.02 2140972 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1 LCP DIA-MTA VLR DSTL RDUS PLT IMPLNT MDUL| MDUL FR VA-LCP 2-CLMN VLR DSTL RDUS PL/NRW