BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURNING HANDLE F/90 SCRWDRVR

    MDR report key: 12642801 · Received October 15, 2021

    Report

    Report Number
    2939274-2021-06137
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Report Date
    September 18, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587013312
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: DZJ, DZI. THE SUBJECT DEVICE IS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. VISUAL INSPECTION: THE TURNING HANDLE F/90 SCREWDRIVER (PART #: 03.505.005, LOT #: 8190032) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DEFECT. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS NOT PERFORMED WITH THE COMPLAINT DEVICE BY ASSEMBLING IT TO ITS MATING DEVICE (PART #: 03.505.004). BOTH ASSEMBLED CORRECTLY WITH NO ISSUE. CONSECUTIVELY THE REMINDER OF THE RETURNED DEVICES (EXCEPT THE CASES) WERE ASSEMBLED TOGETHER. BY TURNING THE COMPLAINT DEVICE, THE SCREWDRIVER AT THE DISTAL END OF THE ASSEMBLY WAS ABLE TO TURN. THE ENTIRE ASSEMBLY PERFORMED AS INTENDED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT ABLE TO BE CONFIRMED AS NO VISUAL DEFECT WAS OBSERVED ON THE RETURNED DEVICE AND THE DEVICE WAS ABLE TO PERFORM AS INTENDED WITH THE MATING DEVICES. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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 - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THEY WERE UNABLE TO STERILIZE/ASSEMBLE THE GEAR NOT MATCHING OR WAS MALFUNCTIONING DURING STERILIZATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TURNING HANDLE F/90 SCREWDRIVER. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538001 TURNING HANDLE F/90 SCRWDRVR SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.005 8190032 10887587013312

    Patients

    Seq Age Sex Outcome Treatment
    1