BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE AO BAYONET SHAFT Ø 6.5 L 135

    MDR report key: 8545355 · Received April 24, 2019

    Report

    Report Number
    3004976965-2019-00008
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 12, 2019
    Report Date
    March 26, 2019
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RECEIVED BY VIANT FOR EVALUATION AND THE REPORTED EVENT IS NON-VERIFIABLE. THE CUSTOMER INDICATED THE INSTRUMENT IS NOT AVAILABLE FOR FURTHER INVESTIGATION AND THEY DO NOT HAVE PICTURES AS WELL. NO DISCREPANCIES WERE DISCOVERED DURING DEVICE HISTORY RECORD (DHR) REVIEW. IF THE COMPLAINT SAMPLE IS RECEIVED BY VIANT, IT WILL BE EVALUATED AND A SUPPLEMENTAL MEDWATCH 3500A EMDR WILL BE SUBMITTED ACCORDINGLY. NO FURTHER INVESTIGATION IS REQUIRED. REPORTED BY DISTRIBUTOR MEDACTA INTERNATIONAL SA.

    Description of Event or Problem · 1

    IT WAS REPORTING DURING A PRIMARY HIP PROCEDURE WHILE ATTEMPTING TO DRILL HOLES IN THE ACETABULUM FOR SCREW PLACEMENT, THE SURGEON BROKE THE FLEXIBLE BAYONET DRILL HOLDER AND HAD TO USE ANOTHER FLEXIBLE BAYONET DRILL HOLDER TO COMPLETE THE CASE. NO FRAGMENTS FROM THE BROKEN INSTRUMENT FELL INTO THE PATIENT. THERE WAS A TWO (2) MINUTE DELAY IN CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339048 FLEXIBLE AO BAYONET SHAFT Ø 6.5 L 135 FLEXIBLE BAYONET SHAFT LXH GREATBATCH MEDICAL 01.26.10.0013 6382130001

    Patients

    Seq Age Sex Outcome Treatment
    1