BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS BROACH HANDLE

    MDR report key: 3121706 · Received May 8, 2013

    Report

    Report Number
    3005180920-2013-00049
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIFFERENTLY FROM WHAT WAS REPORTED IN THE INITIAL REPORT, THE BROKEN PEG WAS RECEIVED BACK AND INSPECTED BY QUALITY CONTROL OPERATOR: THE BREAKAGE WAS CONFIRMED AND WAS LIKELY DUE TO REPEATED LOADS THAT PROGRESSIVELY LED TO ITS BREAKAGE.

    Additional Manufacturer Narrative · 1

    THE MOBILE PIN BROKE, PROBABLY DUE TO REPEATED LOADING AND UNLOADING THAT PROGRESSIVELY STRESSED AND WEAKENED THE BROACH HANDLE. FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED ((B)(4)) NO PARTICULAR ANOMALIES WERE FOUND RELATED TO THE PROBLEM. THE BROKEN PEG HAS BEEN THROWN AWAY IN THE HOSP. THIS IS THE SECOND CASE OF BREAKAGE ON HANDLES OF THIS LOT; THE PREVIOUS ONE WAS REPORTED WITH MDR 2013-00037. ON THE BASIS OF MEDACTA'S RISK ANALYSIS, THE FAILURE MODE IS UNLIKELY TO CAUSE PT HARM SINCE, IN CASE OF MFG OF THE BROACH HANDLE, A SECOND BROACH HANDLE IS ALWAYS AVAILABLE IN THE INSTRUMENTATION KIT, PERMITTING THE SURGEON TO COMPLETE THE SURGERY SUCCESSFULLY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202265 AMIS BROACH HANDLE REUSABLE SURGICAL INSTRUMENTS FOR HIP LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1