BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3230928 · Received July 17, 2013

    Report

    Report Number
    0009610622-2013-00393
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    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: EVALUATION REVEALED THE TARGET DEVICE AS PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. 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. 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 MISS-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. 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. REASONS FOR MISALIGNED DRILLING ARE VARIOUS. POTENTIAL MISS-TARGETING CAN ALSO BE CAUSED BUT IS NOT LIMITED BY, 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 CENTER TIP / UNFAVORABLE 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 (B)(4) (IMPROVED DRILL GUIDING FEATURE) INSTEAD OF (B)(4) MAY EASE THE DISTAL LOCKING PROCEDURE. REGARDING MISS-DRILLING THE OPERATIVE TECHNIQUE HAS ALREADY BEEN MODIFIED. 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

    IT WAS REPORTED THAT SOME DISTAL MISDRILINGS HAPPENED WITH THE REPORTED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME DISTAL MISS DRILLINGS HAPPENED WITH THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330731 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KME901560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other