BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3123663 · Received May 22, 2013

    Report

    Report Number
    0009610622-2013-00272
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE DOES MATCH THE REPORT, AND THE EVENT WAS CONFIRMED. DEVIATIONS IN THE INSPECTION DOCUMENTS WERE NOT FOUND. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY AS NO DISCREPANCIES WERE IDENTIFIED, THEREFORE NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS TIME. THE BREAKAGE SURFACE AT THE CONNECTING RIM OF THE RECEPTION AND THE BROKEN OFF PIECE SHOW TYPICAL TRACES OF A BRITTLE BREAKAGE LIKE NO PLASTIC DEFORMATION WHICH SUGGESTS THAT SUDDEN FORCE WAS APPLIED (E.G. ACCIDENTALLY DROPPED OR HAMMER-BLOWS UPON RE-POSITIONING OR REMOVAL OF THE NAIL). FURTHERMORE PRE-DAMAGES IN FORMER SURGERIES CANNOT BE EXCLUDED. FUNCTIONAL CHECK REVEALED THAT THE SLEEVE COULD NOT BE HELD AS INTENDED FROM THE TARGET DEVICE DUE TO THE BROKEN OFF PIECE AT THE RECEPTION. THUS FUNCTION WAS NOT GIVEN ANY MORE. EVALUATION REVEALED THAT THE PARTLY BROKEN OFF RIM IS NOT LINKED TO ANY DEFICIENCY OF THE DEVICE BUT RATHER RELATED TO INTRA-OPERATIVE DAMAGE BY ROUGH HANDLING AT USER SITE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET DEVICE "HOOKS".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET DEVICE "HOOKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226035 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT HSB STRYKER OSTEOSYNTHESIS-KIEL KME902819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other