BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS DRILL

    MDR report key: 14637046 · Received June 8, 2022

    Report

    Report Number
    3006742481-2022-00004
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 7, 2022
    Report Date
    June 8, 2022
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HTW
    PMA / PMN Number
    K200367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. FLOUROSCOPY IMAGES WERE PROVIDED. AS PER AVAILABLE INFORMATION, IT APPEARS THAT FAILURE TO FOLLOW THE SURGICAL TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT. THE SURGEON OPTED TO NOT RETRIEVE THE DRILL FRAGMENT. ALTHOUGH THE DRILL FRAGMENT REMAINED IN THE PATIENT, THERE WAS NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS CASE.

    Description of Event or Problem · 0

    A DRILL BIT BROKE INSIDE THE PATIENT'S BONE WHILE DRILLING THE FINAL HOLE FOR THE IMPLANT. THE SURGEON DID NOT ATTEMPT TO REMOVE THE BROKEN PIECE OF THE DRILL, BUT WAS ABLE TO COMPLETE THE PROCEDURE SUCESSFULLY. THE SURGEON HAS NOT REPORTED ANY IRREGULARITIES REGARDING THE PATIENT'S STATUS AND NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735679 SKELETAL DYNAMICS DRILL DRILL, 3.2MM X 50MM HTW SKELETAL DYNAMICS DV2106002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other