BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11012540 · Received December 15, 2020

    Report

    Report Number
    3008951116-2020-00010
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 15, 2020
    Manufacturer
    ORTHO SOLUTIONS UK LTD
    Product Code
    HTW
    UDI-DI
    05055662931105
    PMA / PMN Number
    K102743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE PRODUCTION BATCH ASSOCIATED WITH THE COMPLAINT WAS REVIEWED TO CONFIRM THAT THE PRODUCTS WERE SUPPLIED IN CONFORMANCE WITH ORTHO SOLUTIONS SPECIFICATIONS. THE DEVICE HISTORY RECORDS FOR THE BATCH CONFIRMED THAT THE PRODUCTS WERE MANUFACTURED TO SPECIFICATION, CONFORMING TO BOTH DIMENSIONAL REQUIREMENTS AND VISUAL QUALITY CONTROL THAT INCLUDES CHECKS FOR THE PRESENCE OF BURRS, SHARP EDGES AND INCLUSIONS. THE RAW MATERIAL CERTIFICATES WERE ALSO REVIEWED TO CHECK THE MATERIAL GRADE, CHEMICAL COMPOSITION AND MATERIAL HARDNESS. THE RAW MATERIAL WAS CONFIRMED TO BE WITHIN SPECIFICATION, AND THE MECHANICAL PROPERTIES WERE ABOVE THE MINIMUM VALUES REQUIRED BY BS (B)(4) AS SPECIFIED ON THE MATERIAL CERTIFICATE. THERE WERE NO DEVIATIONS FROM SPECIFICATION AND NO CONCESSION WAS RAISED FOR THIS BATCH. THE FAILURE RATE IS (B)(4) WHICH IS DEEMED LOW. VISUAL INSPECTION OF THE RETURNED DRILL CONFIRMED THE REPORTED COMPLAINT CONDITION AND SHOWED THAT THE DEVICE MAY HAVE FRACTURED UPON INITIAL USE. BASED ON THE INVESTIGATION AND THE LIMITED CLINICAL INFORMATION PROVIDED AND THE LACK OF THE X-RAY, THE ROOT CAUSE FOR THE DRILL BIT FRACTURE WAS UNABLE TO BE ASCERTAINED. THE COMPLAINT DID NOT IDENTIFY ANY NEW OR EMERGING RISKS. ALTHOUGH THE ROOT CAUSE COULD NOT BE DEFINITIVELY ASCERTAINED, THE INVESTIGATION DID NOT IDENTIFY ANY DEFICIENCY OR DEVIATION WITH THE DRILL.

    Description of Event or Problem · 1

    DRILL BROKEN DURING A TOTAL HIP REPLACEMENT PROCEDURE; THE DRILL TIP COULDN'T BE FOUND AND SUBSEQUENTLY, AN X-RAY WAS CALLED INTO THEATRE TO IDENTIFY THE DRILL TIP. THE FRAGMENT WAS FOUND NEAR THE STEM, SO IT WOULD CAUSE MORE DAMAGE TRYING TO RETRIEVE IT. NO OTHER CLINICAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475368 AO QC DRILL BIT 2.5/110/85 (GOLD) FLUTED SURGICAL DRILL BIT, SINGLE-USE HTW ORTHO SOLUTIONS UK LTD OS200125 1116052 05055662931105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other