BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 3842468 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19851
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ? REG.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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

    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

    ADDITIONAL NARRATIVE: EXAMINATION OF THE SUBMITTED IMPACTOR CONFIRMED THE FRACTURE INITIATION ALONG THE SLOT THAT CONNECTS WITH THE UNIVERSAL HANDLE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE THROUGH MISALIGNMENT. THE FLAT OF THE IMPACTOR EXHIBITS GOUGING INDICATING THE IMPACTOR WAS NOT PROPERLY ALIGNED PRIOR TO IMPACTION. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR THROUGH TREND ANALYSIS. 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.

    Description of Event or Problem · 1

    HP TIBIAL IMPACTOR TIP BROKE AT THE TOP WHERE IT CONNECTS TO THE UNIVERSAL HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321016 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ? REG. J0608

    Patients

    Seq Age Sex Outcome Treatment
    1