BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK

    MDR report key: 4113943 · Received September 24, 2014

    Report

    Report Number
    0008031020-2014-00441
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    HRS
    PMA / PMN Number
    K141430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE DEPTH GAUGE BREAKAGE COULD BE CONFIRMED, SINCE THE DEVICE WAS RECEIVED AND MET THE REPORTED FAILURE MODE. ACCORDING TO THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A R&D-RELATED ISSUE. DURING PMS TRENDING, A POTENTIAL RECURRING SITUATION WAS IDENTIFIED FOR THE DEVICE AND THE FAILURE MODE AT ISSUE. THEREFORE, A POTENTIAL NC (#827336) WAS OPENED. DURING THIS POTENTIAL NC INVESTIGATION, IT WAS FOUND THAT THE REFS IDENTIFIED IN THE POTENTIAL NC HAD A SIMILAR DESIGN TO THE ONES ALREADY ADDRESSED BY CAPA #(B)(4) (STATING THAT THE MATERIAL COMBINATION OF HOOK AND PLUNGER WAS HARD TO WELD AND THAT WHEN BENDING THE DEPTH GAUGE, THE BENDING FORCES ACTED DIRECTLY ON THE WELDING SEAM LEADING POTENTIALLY TO THE BREAKAGE). THEREFORE, IT WAS DECIDED TO IMPLEMENT THE DESIGN IMPROVEMENT OF CAPA #(B)(4) FOR THE ADDITIONAL REFS OF THIS POTENTIAL NC, AND THUS FOR THE REF AT ISSUE (62-00018). PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. 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 OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE PIN OF DEPTH GAUGE WAS REMOVED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE PIN OF DEPTH GAUGE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593750 DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK PLATE, FIXATION, BONE HRS STRYKER GMBH (MDR) W14854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other