BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ROD T2 FEMUR Ø9 MM

    MDR report key: 3123662 · Received May 22, 2013

    Report

    Report Number
    0009610622-2013-00275
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    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

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED BOTH INSTRUMENTS TO BE PRIMARY PRODUCTS. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. THE DAMAGED THREADS INDICATE THAT BOTH INSTRUMENTS WERE INSERTED IN OBLIQUE MODE AND CROSS THREADING OCCURRED. BOTH INSTRUMENTS ARE MADE OF THE SAME MATERIAL AND WERE BOTH HARDENED TO APPROX. 47 HRC, THEREFORE IT COULD NOT BE DETERMINED WHICH INSTRUMENT CAUSED THE THREAD DAMAGES. IT IS POSSIBLE THAT BOTH THREADS WERE FULLY FUNCTIONAL PRIOR THE ASSEMBLING BUT A PRE-DAMAGING COULD ALSO NOT BE EXCLUDED. HOWEVER, INSERTION IN AN OBLIQUE MODE IS CLASSIFIED AS USER ERROR. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS HAVE BECOME WEDGED INTO EACH OTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS HAVE BECOME WEDGED INTO EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225592 UNIVERSAL ROD T2 FEMUR Ø9 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K183750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other