BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 ANTERIOR BROACH HANDLE

    MDR report key: 6087973 · Received November 8, 2016

    Report

    Report Number
    1818910-2016-31125
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL TEST WITH A MATING BROACH FOUND THE BROACH HANDLES LOCK ONTO THE BROACH; HOWEVER, THE HANDLES ARE LOOSE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE AND WEAR; DAMAGE TO THE CAM COMPONENTS. 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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 HANDLES WERE FOUND BEFORE THE CASE IN THE SET AND NO LONGER WILL LOCK THE BROACH ON CORRECTLY. THE LOCKING MECHANISM DOES NOT WORK ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737269 CORAIL2 ANTERIOR BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. 1818910 NB47722

    Patients

    Seq Age Sex Outcome Treatment
    1