BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3® 300X160MM

    MDR report key: 4142500 · Received October 6, 2014

    Report

    Report Number
    0009610622-2014-00539
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    REVIEW OF THE INSPECTION RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2013) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS REPORTED. THE ALLEGED EVENT OF ¿DISTAL FAILLOCKINGS¿ WAS NOT CONFIRMED. FUNCTIONAL TEST REVEALED NEITHER PROXIMAL NOR DISTAL CONTACTS OF THE DRILLS TO THE DRILL HOLES OF A SAMPLE NAIL. THE FUNCTION OF THE TARGET DEVICE RETURNED IS FULLY GIVEN. POTENTIALLY REDUCED ACCURACY IN GUIDANCE IS USUALLY FOUND DURING FUNCTIONAL CHECK WHICH IS REQUIRED PER IFU. IN CASE OF ANY DEVIATION IT IS REALIZED PRIOR TO USE. PRE-SUPPOSING THAT TARGETING ACCURACY FOR DRILLING WAS CONFIRMED BY PRE-OPERATIVE CHECK IT WAS CONCLUDED THAT THE EVENT(S) WERE MAINLY BASED IN THE INTRA-OPERATIVE PROCEDURE. ALTHOUGH A REAL ROOT CAUSE COULD NOT BE DETERMINED THE ALLEGED EVENT IS MOST LIKELY CAUSED DUE TO A SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE HOSPITAL THAT THE TARGET DEVICE HAD DISTAL FAILED LOCKINGS. A REPLACEMENT WAS AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE HOSPITAL THAT THE TARGET DEVICE HAD DISTAL FAILED LOCKINGS. A REPLACEMENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624154 TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL KME905268

    Patients

    Seq Age Sex Outcome Treatment
    1