BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW GAUGE T2 FEMUR

    MDR report key: 3852596 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00265
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE SCREW GAUGE HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2005), WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS REPORTED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE SPRING THAT HOLDS THE MEASURING HOOK IN THE CORRESPONDING SLEEVE IS BROKEN OFF. THE APPEARANCE OF THE BREAKAGE SURFACE INDICATES A FORCED FRACTURE DUE TO OVERLOAD CAUSED BY BENDING STRESSES, MOST LIKELY DURING CLEANING SUPPORTED BY REMARKABLE SCRATCHES AND DENTS IN THE SLOT. IN CASE OF INTENDED USE SUCH DAMAGE WOULD NOT HAVE OCCURRED. BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO IMPROPER HANDLING BY THE USER. NO NON-CONFORMITY WAS IDENTIFIED.

    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, IT WAS FOUND THAT THE DEPTH GAUGE WAS BROKEN.

    Description of Event or Problem · 1

    DURING THE INSPECTION, IT WAS FOUND THAT THE DEPTH GAUGE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332729 SCREW GAUGE T2 FEMUR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K733547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other