BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL BROACH HANDLE

    MDR report key: 6192935 · Received December 21, 2016

    Report

    Report Number
    1818910-2016-33787
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT THE BROACH HANDLES WERE NOT LOCKING ONTO BROACHES. THE DEVICES ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED. IT IS REPORTED THAT AN ENGINEERING ASSESSMENT WAS PERFORMED. THE ANALYSIS CONCLUDED THAT THERE IS EXTENSIVE IMPACTION DAMAGE TO BOTH THE BROACH HANDLES AND ALSO CRACKS CAN BEEN SEEN AROUND THE PIVOT PINS ON BOTH BROACH HANDLES. THE ASSESSMENT IS THAT THIS COMPLAINT IS DUE TO WEAR AND TEAR. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODES AND LOTS COMBINATIONS. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT IS DUE TO WEAR AND TEAR. 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

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

    Description of Event or Problem · 1

    BROACH HANDLES NOT LOCKING ONTO BROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845801 CORAIL BROACH HANDLE HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. J0208

    Patients

    Seq Age Sex Outcome Treatment
    1