BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW AXSOS 4.0MM / L60MM

    MDR report key: 2231484 · Received July 22, 2011

    Report

    Report Number
    8031020-2011-00164
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K050512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE MFG DOCUMENTS, THE INSPECTION PROTOCOL AND THE RAW MATERIAL CERTIFICATE OF THE RETURNED SCREW HEAD WERE REVIEWED AND NO DEVIATION FROM SPEC WAS NOTED. THE DEVICE WAS MFG ACCORDING TO DRAWING REV B IN 2006. SIMILAR COMPLAINT ISSUES INITIATED THE LAST CHANGE REQUEST IN 2006. ACTUAL DESIGN REV C. DUE TO ABOVE MENTIONED REASONS THE COMPLAINT ISSUE IS CONSIDERED AS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SALES REP THAT, DURING A SURGERY (AXSOS, PROXIMAL TIBIA), WHEN THE SURGEON SCREWED THE SECOND LOCKING SCREW, (B)(4), THE DYNAMOMETER DID NOT CLICK (TO IDENTIFIED 4N). WHEN THE SURGEON SCREWED THE THIRD LOCKING SCREW, (B)(4), THE DINAMOMETER DID NOT CLIK (TO IDENTIFIED 4N) AND WHEN THE SURGEON RETRIEVED THE DINAMOMEMTER, IT WAS DETECTED THAT THE SCREW WAS BROKEN. THE HEAD OF THE LOCKING SCREW IS AVAILABLE TO STRYKER TO BE INVESTIGATED AND THE REST OF THE SCREW REMAINS IMPLANTED. IT HAS BEEN ALLEGED BY OUR CUSTOMER VIA SALES REP THAT THE THIRD SCREW WAS FIXED COMPLETELY. NO MORE ADVERSE CONSEQUENCE WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW AXSOS 4.0MM / L60MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA M10166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other