BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 STRAIGHT BROACH HANDLE

    MDR report key: 6051170 · Received October 24, 2016

    Report

    Report Number
    1818910-2016-30028
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: HANDLE IS VERY LOOSE AND NO LONGER HOLDS ONTO BROACH. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER SIMILAR REPORTS AGAINST THE PART/LOT WITH THE ROOT CAUSE FINDING OF INSTRUMENT MISUSE/HEAVY USE. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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.

    Description of Event or Problem · 1

    HANDLE IS VERY LOOSE AND NO LONGER HOLDS ONTO BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703402 CORAIL2 STRAIGHT BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. 1818910 J0411

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR