BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - INSERTION INSTRUMENTS: TRAUMA

    MDR report key: 12722807 · Received October 29, 2021

    Report

    Report Number
    2939274-2021-06384
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Report Date
    October 3, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510K: THIS REPORT IS FOR AN UNK - INSERTION INSTRUMENTS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, 90 DEGREE ARM FOR 90 DEGREE SCREWDRIVER DOES NOT CLICK INTO A 90-DEGREE PIECE. THE PIECE IS THE INSERT OF THE 90-DEGREE ARM. THIS WAS DISCOVERED DURING AN INSPECTION WHILE CLEANING IT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNK - INSERTION INSTRUMENTS: TRAUMA. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617414 UNK - INSERTION INSTRUMENTS: TRAUMA MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 SHAFT 90| UNK TURNING HANDLE| UNKNOWN GUIDES/SLEEVES/AIMING| UNKNOWN HANDLES