BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA CURVED BROACH HANDLE

    MDR report key: 6186018 · Received December 19, 2016

    Report

    Report Number
    1818910-2016-33645
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL TEST WITH A MATING BROACH CONFIRMED THE COMPLAINT; THE HANDLE NO LONGER LOCKS. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR, DAMAGE WAS FOUND TO THE CAM COMPONENT. IT IS IMPORTANT TO ENSURE THAT THE ALIGNMENT FEATURES ON BOTH THE HANDLE AND BROACH ARE MATED CORRECTLY, AS PROPER LOCKING WILL EXTEND THE LIFE OF ALL BROACH HANDLES. IF THESE ORIENTATION FEATURES ARE NOT ALIGNED PROPERLY, THE CAM WILL LOCK INCORRECTLY ONTO THE BROACH. AFTER THIS TYPE OF DEFORMATION OCCURS, THE HANDLE WILL NO LONGER LOCK AS TIGHTLY ONTO THE BROACH AS WHEN FIRST DISTRIBUTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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

    THE BROACH HANDLE NO LONGER STAYS CLOSED AND LOCKED INTO BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838270 EXTRA CURVED BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. RA248A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR