BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 4161948 · Received October 10, 2014

    Report

    Report Number
    1818910-2014-29779
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 HANDLE END CAP BREAKAGE. PREVIOUSLY, SEVEN PINNACLE STRAIGHT IMPACTORS (P/N 221750041) WERE EVALUATED. LIKE THE OTHER IMPACTORS EVALUATED, THIS ONE WAS FRACTURED THROUGH THE PINNACLE IMPACTOR END CAP (P/N 221750018). THE DISTAL FRACTURE SURFACE OF THE END CAP WAS EXAMINED USING STEREOMICROSCOPY AND SCANNING ELECTRON MICROSCOPY. ON THE BASIS OF THESE OBSERVATIONS, THIS IMPACTOR FRACTURED IN THE SAME MANNER AS THOSE PREVIOUSLY EVALUATED. THE IMPACTOR WAS 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 AT THIS TIME. 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

    SURGEON WAS HAMMERING CUP WITH IMPACTOR AND IT BROKE DOWN. THIS HAPPENED AT SUMMER AND I WAS INFORMED ABOUT IT NOW. NO PATIENT INFORMATION. SOMETHING WRONG WITH IMPACTOR? IT IS QUITE A NEW IMPACTOR AND HAS BEEN USED ABOUT 6 MONTHS. DATE OF EVENT IS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643666 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. NB50255

    Patients

    Seq Age Sex Outcome Treatment
    1