BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT UNIVERSAL BROACH HANDLE

    MDR report key: 6119982 · Received November 22, 2016

    Report

    Report Number
    1818910-2016-31940
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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 CHECK WITH A MATING BROACH CONFIRMED THE COMPLAINT; THE BROACH WAS SLIGHTLY LOOSE WHEN ATTACHED TO THE HANDLE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE AND WEAR; DAMAGE 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. THE DATE CODE INDICATES THE INSTRUMENT WAS MANUFACTURED IN SEPTEMBER OF 2006 AND IS OVER 10 YEARS OLD. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE BROACH IS LOOSE WHEN FASTENED TO BROACH HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773525 SUMMIT UNIVERSAL BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. AK0906

    Patients

    Seq Age Sex Outcome Treatment
    1