BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3® 300X160MM

    MDR report key: 3940093 · Received July 17, 2014

    Report

    Report Number
    0009610622-2014-00341
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 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

    EVALUATION SUMMARY: PRODUCT INQUIRY STATES THE TARGET DEVICE GAMMA3 TO BE THE SUBJECT PRODUCT. THE SPEEDLOCK SLEEVE RETURNED IS CONSIDERED AS AN ASSOCIATED PRODUCT. THE APPEARANCE OF THE ITEM AND THE INSPECTION RECORDS IDENTIFIED THE TARGET DEVICE RETURNED BEING A NEW DESIGN VERSION. A REVIEW OF THE INSPECTION RECORDS REVEALED NO DISCREPANCIES. A CHECK OF THE FUNCTION ON 100% OF THE DEVICES (SUB-SUPPLIER) AND ADDITIONAL IN-HOUSE SPOT CHECK OF THE LOT IN QUESTION REVEALED THAT FUNCTION WAS GIVEN IN FULL ON THE DEVICES AT THE STAGE OF DELIVERY. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2008) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS REPORTED. 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. THE ALLEGED TARGETING INACCURACY COULD NOT BE REPRODUCED. POTENTIALLY REDUCED ACCURACY IN GUIDANCE IS USUALLY FOUND DURING FUNCTIONAL CHECK (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 NURSE THAT A TARGETING INACCURACY HAS BEEN OBSERVED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE THAT A TARGETING INACCURACY HAS BEEN OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418491 TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL KME902060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other