BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE

    MDR report key: 3093923 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01563
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT VISUAL INSPECTION: THE LEVER OF THE HANDLE FRACTURED OFF, CONFIRMING THE REPORTED EVENT. THE EVENT WAS CONFIRMED. THE DEVICE WAS DETERMINED TO BE WITHIN THE SCOPE OF NCR, WHICH WAS INITIATED DUE TO AN INCONSISTENCY BETWEEN HARDNESS CALLOUTS ON THE LATCH LEVER COMPONENT DRAWINGS AND THE MEASURED HARDNESS OF THE PARTS, WHICH WERE IN AGREEMENT WITH THE MATERIAL SPECIFICATION. ECN WAS RAISED TO REMOVE THE HARDNESS REQUIREMENT ON THE DRAWING, WHICH IS NOW CONTROLLED BY THE MATERIAL SPECIFICATION, AND TO CHANGE THE BLEND RADIUS AND WIDTH TO DECREASE THE MAX PRINCIPAL STRESSES ON THE AFFECTED AREAS OF THE LEVER ARM. ADDITIONALLY, THERE WAS SEVERE IMPACTION MARKS ON AND AROUND THE LEVER ARM, INDICATING IT WAS STRUCK WITH A MALLET TO RELEASE THE HANDLE REPEATEDLY. THE HANDLE IS TO BE IMPACT ON THE STRIKE PLATE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BROACH HANDLE WAS NOT ENGAGING CORRECTLY ON REMOVAL OF FINAL BROACH. BROACH DID COME OUT BUT DID NOT STAY CONNECTED TO HANDLE. AT THAT POINT WE NO LONGER NEEDED THE HANDLE ANYWAY AND PROCEEDED WITH CASE WITHOUT DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BROACH HANDLE WAS NOT ENGAGING CORRECTLY ON REMOVAL OF FINAL BROACH. BROACH DID COME OUT BUT DID NOT STAY CONNECTED TO HANDLE. AT THAT POINT WE NO LONGER NEEDED THE HANDLE ANYWAY AND PROCEEDED WITH CASE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196106 RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P6K42

    Patients

    Seq Age Sex Outcome Treatment
    1 Other