BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR ASSEMBLY OMEGA

    MDR report key: 4120502 · Received September 26, 2014

    Report

    Report Number
    0008031020-2014-00446
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE IMPACTOR BREAKAGE COULD BE CONFIRMED, SINCE THE RETURNED DEVICE MATCHED THE REPORTED FAILURE. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY THE APPLICATION OF EXCESSIVE FORCE ON THE DEVICE. THE VISUAL INSPECTION REVEALED THAT THE BREAKAGE IS CONSISTENT WITH THE APPLICATION OF A HIGH FORCE ON THE DEVICE. NOTE, AS STATED IN THE OPERATIVE TECHNIQUE: ¿IMPACTION OF THE FRACTURE MAY BE ACCOMPLISHED BY USING THE PLATE IMPACTOR TOGETHER WITH A HAMMER OR MALLET. NOTE: USE GENTLE HAMMERING ONLY - OTHERWISE THE IMPACTOR MAY BE DESTROYED.¿ A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE IMPACTOR BROKE. ACCORDING TO SALES REP, DURING SURGERY WHEN THE SURGEON USED THE HAMMER, THE IMPACTOR BROKE. ALL FRAGMENTS WERE DISCARDED IN THE HOSPITAL.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE IMPACTOR BROKE. ACCORDING TO SALES REP, DURING SURGERY WHEN THE SURGEON USED THE HAMMER, THE IMPACTOR BROKE. ALL FRAGMENTS WERE DISCARDED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600631 IMPACTOR ASSEMBLY OMEGA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH D00501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other