BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 4233322 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31350
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF END CAP HANDLE BREAKAGE. PREVIOUS EVALUATIONS BY DEPUY MATERIAL SCIENCE FOUND 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. THE ROOT CAUSE IS ATTRIBUTED TO DEVICE OVERLOAD BASED ON SIMILAR EVALUATIONS. BASED ON THE PERFORMED INVESTIGATION, CORRECTIVE ACTION IS NOT NEEDED. CONTINUE TO MONITOR VIA SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    WHEN THE PINNACLE CUP WAS BEING IMPACTED INTO THE PATIENT, THE END OF THE IMPACTOR BROKE OFF WHEN IT WAS STRUCK BY THE MALLET. ALL PIECES WERE ACCOUNTED FOR AND NONE FELL INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713314 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 NB55897

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR