BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO QC DRILL BIT 2.5/110/85 (GOLD)

    MDR report key: 11397749 · Received March 2, 2021

    Report

    Report Number
    3008951116-2021-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 2, 2021
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    UDI-DI
    05055662931105
    PMA / PMN Number
    K102743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS RISK ASSESSED AS MEDIUM RISK. HISTORICAL ANALYSIS OFTHE DRILL BATCH IDENTIFIED THAT THIS WAS THE FIRST REPORTED ISSUE FOR THIS BATCH. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE PRODUCT WAS SUPPLIED IN CONFORMANCE WITH ORTHO SOLUTIONS SPECIFICATIONS. NO ANOMALIES OR DEVIATIONS WERE NOTED IN THE MANUFACTURE OF THIS BATCH OF DRILLS WHICH MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DRILL BIT DURING OPERATION. THUS, THE MANUFACTURE OF THE BATCH IS THEREFORE NOT LIKELY TO HAVE BEEN A CAUSE FOR THE DRILL FRACTURE REPORTED. VISUAL ANALYSIS OF THE RETURNED DRILL SECTION DID NOT SHOW ANY INDICATIVE FEATURES TO POINT TOWARDS A CLEAR ROOT CAUSE FOR THE FRACTURE, AND DID NOT UNDERMINE THE DOCUMENTED CONFORMANCE TO SPECIFICATION AS REVIEWED. DUE TO THE LIMITED CLINICAL INFORMATION AND NO AVAILABLE IMAGING OF THE RETAINED DRILL SECTION, THE ROOT CAUSE THEREFORE COULD NOT BE ASCERTAINED. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF FAILURE, THE FAILURE RATE FOR THE PRODUCT REMAINS TO BE LOW.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A QUADS REPAIR SURGICAL PROCEDURE, THE DRILL BIT FRACTURED DURING USE TO DRILL SOFT BONE. THE DRILL TIP WAS RETAINED WITHIN THE PATIENT, AND WAS UNABLE TO BE RETRIEVED. NO ADDITIONAL COMPLICATIONS WERE REPORTED FOR THE PATIENT AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295640 AO QC DRILL BIT 2.5/110/85 (GOLD) FLUTED SURGICAL DRILL BIT, SINGLE-USE, PRODUCT CODE: HTW HTW ORTHO SOLUTIONS UK LTD OS200125 1118808 05055662931105

    Patients

    Seq Age Sex Outcome Treatment
    1