BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN LOOP TENDON STRIPPER

    MDR report key: 8296436 · Received February 1, 2019

    Report

    Report Number
    1017294-2019-00004
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 4, 2019
    Report Date
    February 1, 2019
    Manufacturer
    CLASSIC WIRE CUT CO, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED USED DEVICE ITEM TS8865 COULD NOT CONFIRM THE REPORTED PROBLEM. RETURNED DEVICE WAS INSPECTED PER PRINT AND INSPECTION PROCEDURE. NO DISCREPANCIES COULD BE FOUND WITH MACHINED CRITICAL DIMENSIONS. PRODUCT IS MACHINED TO REQUIRED SPECIFICATIONS AND NO SHARP EDGES WERE FOUND WHEN INSPECTED UNDER THE MICROSCOPE. THERE HAS BEEN ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TS8865 OPEN LOOP TENDON STRIPPER DEVICE TORE MUSCLE OFF THE HAMSTRING TENDON AND DID NOT CUT THE TENDON PROPERLY DURING AN ACL PROCEDURE ON (B)(6) 2019. THE SURGEON THEN INSERTED A COMPETITOR DEVICE TO COMPLETE THE PROCEDURE. THE PROCEDURE DID NOT RESULT IN ANY TYPE OF INJURY TO THE PATIENT OR USER, NOR WAS ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION REPORTED. THE PROCEDURE WAS COMPLETED AS NORMAL WITH A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO A SECOND ATTEMPT TO RETRIEVE THE MUSCLE BEING REQUIRED SINCE THE TS8865 TORE THE MUSCLE ON THE FIRST ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89634 OPEN LOOP TENDON STRIPPER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CLASSIC WIRE CUT CO, INC. 48450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other