BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3230948 · Received July 17, 2013

    Report

    Report Number
    0009610622-2013-00397
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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: APPEARANCE OF ITEM AND INSPECTION RECORDS IDENTIFIED THE TARGET DEVICE RETURNED BEING OF NEW DESIGN VERSION. DEVIATIONS IN THE INSPECTION DOCUMENTS WERE NOT FOUND. A CHECK OF THE FUNCTION ON 100% OF THE DEVICES (SUB-SUPPLIER) AND ADDITIONAL IN-HOUSE SPOT CHECK OF THE LOT IN QUESTION REVEALED FUNCTION WAS GIVEN IN FULL ON THE DEVICES AT THE STAGE OF DELIVERY. THE OBSERVED IMPACTS IN THE CFR-MATERIAL ON THE CURVED LOWER SIDE OF THE TARGETING ARM ARE DUE TO HAMMERING ON TO THE DEVICE WHICH IS REGARDED AS IMPROPER HANDLING. 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 WAS FULLY GIVEN. THE ALLEGED DISTAL MIS-TARGETING 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. REASONS FOR MISALIGNED DRILLING ARE VARIOUS. POTENTIAL MISS-TARGETING CAN ALSO BE CAUSED BUT IS NOT LIMITED BY E.G. LOOSENING OF THE NAIL HOLDING BOLT DURING INSERTION OF THE NAIL. REPEATED TIGHTENING OF THE NAIL HOLDING SCREW PRIOR TO DISTAL TARGETING / DRILLING IS RECOMMENDED. NOT REALIZED UNINTENDED LOOSENING OF THE ATTACHMENT KNOB (WILL LEAD TO RELEASE OF THE DRILL SLEEVE). NO USE OF DRILL WITH CENTRE TIP / UNFAVOURABLE BONE CONTOUR. DRILLING WITHOUT DRILL GUIDING SLEEVE. USING BLUNT OR DAMAGED DRILL. HIGH FORCES APPLIED TO THE TARGET DEVICE DURING DRILLING EVENTUALLY LEADING TO UNINTENDED DISTORTION IN THE SYSTEM OF DRILL, SLEEVE, TARGET DEVICE AND NAIL. THE USAGE OF THE ¿NEW¿ DRILL GUIDE SLEEVE 1320-0215 (IMPROVED DRILL GUIDING FEATURE) INSTEAD OF 1806-0215 MAY EASE THE DISTAL LOCKING PROCEDURE. REGARDING MIS-DRILLING THE OPERATIVE TECHNIQUE HAS ALREADY BEEN MODIFIED. THE NATURE OF THE FRACTURE DETERMINES WHETHER THE DISTAL LOCKING SCREW IS USED. IT SHOULD BE USED: IF THE FRACTURE IS UNSTABLE; IF ROTATIONAL STABILITY IS REQUIRED; WHEN THERE IS A WIDE DISPARITY BETWEEN THE DIAMETER OF THE NAIL AND THE FEMORAL CAVITY. IF AND IN WHICH MANNER DISTAL LOCKING IS PERFORMED IS IN THE JUDGMENT OF THE TREATING SURGEON. REFERRING TO RECEIVED INFORMATION IT IS SUGGESTED THAT POTENTIAL DEVIATION IN TARGETING ACCURACY SHOULD HAVE BEEN DETECTED DURING REQUIRED FUNCTIONAL CHECK PRIOR TO USE. NO INFORMATION WAS GIVEN WHICH KIND OF NAIL HAD BEEN USED. FURTHER, THE KIND OF PREPARING THE INTRAMEDULLARY CANAL MAY BE ESSENTIAL FOR INSERTING THE NAIL WITHOUT DEFLECTION. DEPENDING ON THE BONE CURVATURE THIS MAY CONTRIBUTE TO SUFFICIENT DRILLING. ALTHOUGH A REAL ROOT CAUSE COULD NOT BE DETERMINED THE ALLEGED EVENT IS MOST LIKELY CAUSED DUE TO A SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE.

    Description of Event or Problem · 1

    SURGEON ATTACHED A NAIL, PLACED A LAG SCREW AND MOVED DISMALLY TO LOCK THE SHORT GAMMA NAIL. HE PLACED THE TROCARS INTO THE TARGETING ARM, TRIED TO DRILL THE HOLE AND GOT HUNG UP. HE EVENTUALLY PASSED THE DRILL TO THE FAR CORTEX. ON FURTHER C ARM EXAMINATION, THE SCREW AND DRILL HOLE WERE POSTERIOR AND MISSED THE SHORT GAMMA NAIL.

    Description of Event or Problem · 1

    SURGEON ATTACHED A NAIL, PLACED A LAG SCREW AND MOVED DISMALLY TO LOCK THE SHORT GAMMA NAIL. HE PLACED THE TROCHARS INTO THE TARGETING ARM, TRIED TO DRILL THE HOLE AND GOT HUNG UP. HE EVENTUALLY PASSED THE DRILL TO THE FAR CORTEX. ON FURTHER C ARM EXAMINATION, THE SCREW AND DRILL HOLE WERE POSTERIOR AND MISSED THE SHORT GAMMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332538 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER TRAUMA KIEL KME902914

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other