BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP MBT CEM KEEL PUNCH SZ 2-3

    MDR report key: 4141488 · Received October 4, 2014

    Report

    Report Number
    1818910-2014-29409
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED DEVICE CONFIRMS ONE OF THE TABS WAS FRACTURED. INITIAL REPORTING STATES ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURES; HOWEVER, HEAVY USAGE OVER TIME AND OR USER ERROR/MISUSE COULD BE CONTRIBUTING FACTORS. (B)(4) HAS BEEN INITIATED TO INVESTIGATE, IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    MBT PUNCH BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621462 HP MBT CEM KEEL PUNCH SZ 2-3 KNEE INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. J0608

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR