BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 10581301 · Received September 24, 2020

    Report

    Report Number
    2939274-2020-04316
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Report Date
    September 1, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. H3, H4, H6- THE SHAFT FOR 90° SCREWDRIVER (P/N: 03.505.003, LOT #: 8192438) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THERE WAS NO DEFECT IDENTIFIED ON THE DEVICE. THE COMPLAINT CONDITION OF STRIPPED CANNOT BE CONFIRMED FOR SHAFT FOR 90° SCREWDRIVER (P/N: 03.505.003, LOT #: 8192438). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WHY THE CUSTOMER EXPERIENCED THE REPORTED PROBLEM. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, 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 HISTORY LOT PART: 03.505.003, LOT: 8192438, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 31 OCT 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 COMPANY 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 (B)(6) 2020, AN INVENTORY CHECK OCCURRED AND MULTIPLE DEVICES INCLUDING A MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER WERE FOUND WITH MALFUNCTIONS. WHEN TESTED, THE DEVICES WOULD NOT WORK PROPERLY; WOULD NOT TURN, HOLD SCREWS, AND SOME WERE STRIPPED. SOME INSTRUMENTS WERE BENT OR DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 3 OF 6 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044865 SHAFT FOR 90 SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.003 8130105 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1