BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW GAUGE, EXTRA SHORT T2 HUMERUS

    MDR report key: 4180033 · Received October 17, 2014

    Report

    Report Number
    0009610622-2014-00555
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 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

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

    Additional Manufacturer Narrative · 1

    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 2004), 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 WITH A FISSURED STRUCTURE AND THE ABSENCE OF PLASTIC DEFORMATION INDICATES A FORCED FRACTURE DUE TO OVERLOAD MOST LIKELY CAUSED BY BENDING STRESSES DURING THE REPROCESSING PROCEDURE SUPPORTED BY THE SCRATCHES AND DENTS AT 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 AND HAS TO BE CLASSIFIED AS MISUSE. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE INNER PIN WAS BROKEN. ACCORDING TO SR, IT WAS USED IN SURGERY WITHOUT ANY PROBLEM.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE INNER PIN WAS BROKEN. ACCORDING TO SR, IT WAS USED IN SURGERY WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662445 SCREW GAUGE, EXTRA SHORT T2 HUMERUS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K787364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other