BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 3864045 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20588
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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.

    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. 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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF HANDLE BREAKAGE. THE RETURNED DEVICE WAS FORWARDED TO METALLURGY FOR EXAMINATION AND ANALYSIS (B)(4). ON THE BASIS OF THESE OBSERVATIONS, THE IMPACTORS WERE REPEATEDLY LOADED IN ROTATING BENDING FATIGUE BEYOND THE MATERIAL LIMIT RESULTING IN FATIGUE CRACK INITIATION AND PROPAGATION WITH MIXED-MODE OVERLOAD FINAL FRACTURE OF THE MATERIAL. NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS WAS OBSERVED THAT COULD CONTRIBUTE TO THE FAILURE OF THESE COMPONENTS. BASED ON THE PERFORMED INVESTIGATION, CORRECTIVE ACTION IS NOT NEEDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE REOPENED AS NECESSARY.

    Description of Event or Problem · 1

    PINNACLE CUP INSERTER BROKE WHILE IMPACTING. THE METAL CAP ON THE BACK OF THE HANDLE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341308 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 NB57441

    Patients

    Seq Age Sex Outcome Treatment
    1