BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT BROACH SZ8

    MDR report key: 1850826 · Received September 28, 2010

    Report

    Report Number
    1818910-2010-06596
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED BROACH CONFIRMS THE INSTRUMENT HAS SUSTAINED GROSS DAMAGE; THE TIP OF THE BROACH HAS BEEN BLUNTED, CONSISTENT WITH IMPACTION. ALTHOUGH, FUNCTIONALLY THE BROACH MATES AND DISENGAGES FROM THE BROACH HANDLE AS INTENDED. THE INSTRUMENT WAS CHECKED WITH CALIBRATED OVERLAYS AND OPTICAL COMPARATORS AND WAS FOUND TO BE DIMENSIONALLY WITHIN SPECIFICATIONS IN BOTH MEDIAL/LATERAL AND ANTERIOR/POSTERIOR VIEWS. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    BROACH BECAME STUCK IN PT, AND IT TOOK 45 MINUTES TO EXTRACT IT. THE FEMUR EVENTUALLY FRACTURES. TOTAL SURGICAL DELAY WAS 3 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT BROACH SZ8 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA PG0208

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention