BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO QC DRILL BIT 3.2/195/170

    MDR report key: 11751388 · Received April 30, 2021

    Report

    Report Number
    3008951116-2021-00003
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 30, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    PMA / PMN Number
    K102743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION, THE ROOT CAUSE FOR THE DRILL FRACTURE WAS UNABLE TO DEFINITIVELY ASCERTAINED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED BATCHES VERIFIED THAT THE DRILLS WERE SUPPLIED IN CONFORMANCE TO THE SPECIFICATIONS. NO DEVIATIONS WERE NOTED WHICH MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE IN ITS INTENDED USE. TREND ANALYSIS FOR THE DRILL SHOWED THAT THIS WAS THE FIRST REPORTED BREAKAGE OF THE DEVICE, AND THE FAILURE RATE IS LOW. NO FURTHER COMPLICATION OR SERIOUS INJURY WAS REPORTED AT THE TIME OF THIS REPORT. NO NEW OR EMERGING RISKS HAVE BEEN IDENTIFIED FROM THE INVESTIGATION. THE DEVICE PERFORMANCE AND REPORTED FAILURE MODE IS TO BE MONITORED VIA POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    DURING A PERIACETABULAR OSTEOTOMY PROCEDURE, THE SURGEON WAS DRILLING THE HIP BONE WHEN THE DRILL BIT REPORTEDLY SNAPPED. HALF OF THE DRILL BIT WAS RETAINED IN THE PATIENT AND THE SURGEON WAS UNABLE TO REMOVE IT WITHOUT FURTHER DAMAGING THE BONE. PATIENT'S BONE QUALITY IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651718 AO QC DRILL BIT 3.2/195/170 FLUTED SURGICAL DRILL BIT, SINGLE-USE HTW ORTHO SOLUTIONS UK LTD OS200132L 1A3046 OR 1113429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other