BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA CURVED BROACH HANDLE

    MDR report key: 6077956 · Received November 3, 2016

    Report

    Report Number
    1818910-2016-30819
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL TEST WITH A MATING BROACH FOUND THE COMPLAINT UNCONFIRMED; THE HANDLES SECURELY LOCKED AND HELD THE MATING BROACH AS INTENDED. 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 AT THIS TIME. 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

    EXTRA CURVED BROACH HANDLE DOES NOT PROVIDE TENSION WHEN CLAMPING DOWN ON BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727101 EXTRA CURVED BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. 1818910 RA268A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR