BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING SLEEVE GAMMA3 180

    MDR report key: 3230945 · Received July 17, 2013

    Report

    Report Number
    0009610622-2013-00394
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER TRAUMA 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 TARGETING SLEEVE AS PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. APPEARANCE OF THE ITEM AND INSPECTION RECORDS IDENTIFIED THE TARGETING SLEEVE RETURNED BEING OF OLD DESIGN VERSION. NO DEVIATIONS WERE FOUND IN THE INSPECTION DOCUMENTS. 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 THE DEVICES WERE FULLY FUNCTIONAL PRIOR TO DELIVERY. A FUNCTIONAL TEST REVEALED THAT THE DISTAL DRILL PASSED THE STATIC- AND DYNAMIC DISTAL DRILL HOLES IN THE NAIL WITH NO CONTACT. THE RETURNED TARGETING SLEEVE IS FULLY FUNCTIONAL. THE ALLEGED MIS-TARGETING COULD NOT BE REPRODUCED. POTENTIALLY REDUCED ACCURACY IN GUIDANCE IS USUALLY FOUND DURING FUNCTIONAL CHECK, WHICH IS REQUIRED PER IFU. IN CASE OF ANY DEVIATION IT IS NOTICED PRIOR TO USE. IF THE TARGETING ACCURACY FOR DRILLING WAS CONFIRMED BY A PERIOPERATIVE CHECK, IT CAN BE CONCLUDED THAT THE REPORTED EVENT WAS MAINLY BASED IN THE INTRA-OPERATIVE PROCEDURE. REASONS FOR MISALIGNED DRILLING ARE VARIOUS. POTENTIAL MIS-TARGETING CAN ALSO BE CAUSED BUT IS NOT LIMITED BY TO: 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. UNNOTICED UNINTENDED LOOSENING OF THE ATTACHMENT KNOB (WILL LEAD TO RELEASE OF THE DRILL SLEEVE). DRILL WITH CENTRE TIP NOT USED / 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 1320-0215 DESIGN (IMPROVED DRILL GUIDING FEATURE) INSTEAD OF 1806-0215 MAY EASE THE DISTAL LOCKING PROCEDURE. REGARDING MIS-DRILLING THE OPERATIVE TECHNIQUE HAS ALREADY BEEN MODIFIED BY ECN (B)(4). BASED ON THE INFORMATION RECEIVED, THAT POTENTIAL DEVIATION IN TARGETING ACCURACY SHOULD HAVE BEEN DETECTED DURING REQUIRED FUNCTIONAL CHECK PRIOR TO USE. NO INFORMATION WAS GIVEN AS TO WHICH KIND OF NAIL HAD BEEN USED. FURTHER, PREPARATION OF 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. THE DEVELOPMENT OF A NEW TARGETING SLEEVE WITH INTEGRATED CLAMPING FUNCTION (COMBINATION OF SLEEVE AND KNOB) IS COMPLETED AND RESULTED IN A NEW DEVICE (GAMMA3 SPEEDLOCK SLEEVE). THE PRODUCT BULLETIN STATES: THE NEW GAMMA3 SPEEDLOCK SLEEVE SAVES ONE STEP IN SURGERY. THE NEW GAMMA3 SPEEDLOCK SLEEVE HAS BEEN DESIGNED AS A RESULT OF OUR CONTINUOUS PRODUCT IMPROVEMENTS AND IT IS THE NEW TARGETING SLEEVE OF WHICH THE CURRENT TARGETING SLEEVE AND THE KNOB ARE MADE IN ONE PIECE. BY ELIMINATING THE ASSEMBLY STEPS, IT PROVIDES MORE INTUITIVE OPERATIVE FLOWS AND PREVENTS THE POTENTIAL MIS-ASSEMBLY OF THE KNOB AND THE TARGETING SLEEVE. AVAILABILITY: STARTING JULY 2009, THE SPEEDLOCK SLEEVE HAS BEEN AVAILABLE TO ALL MARKETS. THE OLD TARGETING SLEEVE AND THE KNOB WERE PHASED OUT.

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT DURING LOCKING, THERE HAS BEEN NO ACCORDANCE OF THE SETTINGS STATIC/DYNAMIC LOCKING WITH BORING OF NAIL. THERE WAS A DELAY OF 15 MIN.

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT DURING LOCKING THERE HAS BEEN NO ACCORDANCE OF THE SETTINGS STATIC/DYNAMIC LOCKING WITH BORING OF NAIL. THERE WAS A DELAY OF 15 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332537 TARGETING SLEEVE GAMMA3 180 INSTRUMENT LXH STRYKER TRAUMA KIEL KHI081643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other