BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSCREW TAP, 7MM

    MDR report key: 228021 · Received June 14, 1999

    Report

    Report Number
    1017294-1999-00023
    Event Type
    Malfunction
    Date Received
    June 14, 1999
    Date of Event
    May 20, 1999
    Report Date
    May 20, 1999
    Manufacturer
    LINVATEC CORP.
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, DR STARTED USING TAP AND HAD THE DEVICE FULLY SEATED. WHEN HE BEGAN TO BACKOUT, THE WELD ON THE TAP BROKE LEAVING A PORTION OF THE TAP IN THE BONE. DR USED ANOTHER INSTRUMENT TO REMOVE BROKEN TAP. EXTENDED SURGERY 20-30 MINS. DR DID NOT HAVE TO OPEN PT TO REMOVE BROKEN TAP. DR NOTED PT HAD VERY HARD BONE. FINISHED CASE WITH NO OTHER PROBLEMS. PT DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSCREW TAP, 7MM SCREW TAP HWX LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R