BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3251449 · Received July 29, 2013

    Report

    Report Number
    0009610622-2013-00418
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 6, 2013
    Report Date
    July 6, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 OLD DESIGN VERSION. DEVIATIONS IN THE INSPECTION DOCUMENTS WERE NOT FOUND. A FUNCTIONAL INSPECTION ON 100% OF THE DEVICES BY THE SUPPLIER AND ADDITIONAL IN-HOUSE SPOT CHECK OF THE LOT IN QUESTION REVEALED FUNCTIONALITY WAS GIVEN ON THE DEVICES AT THE STAGE OF DELIVERY. THE ITEM RETURNED WAS DOCUMENTED AS HAVING MET SPECIFICATIONS PRIOR TO DISTRIBUTION. A FUNCTIONAL TEST REVEALED SLIGHT CONTACTS OF THE DRILL TO THE DRILL HOLES WHICH INDICATE A MISTARGETING BUT ARE NOT IN SUCH A WAY THAT A REAL MISDRILLING (DRILL DOES NOT PASS THE DRILL HOLES) WOULD OCCUR. ALTHOUGH CRACKED - THE FUNCTIONALITY OF THE RETURNED TARGET DEVICE WAS SUFFICIENTLY GIVEN FOR SURGERY. 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. IT WAS CONCLUDED THAT THE EVENT(S) WERE MAINLY BASED IN THE INTRA-OPERATIVE PROCEDURE. REASONS FOR MISALIGNED DRILLING ARE VARIOUS. POTENTIAL MIS-TARGETING CAN ALSO BE CAUSED BUT IS NOT LIMITED 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. - UNINTENDED LOOSENING OF THE ATTACHMENT KNOB (WILL LEAD TO RELEASE OF THE DRILL SLEEVE). - NO USE OF DRILL WITH CENTRE 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 1320-0215 (IMPROVED DRILL GUIDING FEATURE) INSTEAD OF 1806-0215 MAY EASE THE DISTAL LOCKING PROCEDURE. REGARDING MISDRILLING THE OPERATIVE TECHNIQUE HAS BEEN MODIFIED BY ECN 6496/08. 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 AS TO WHICH KIND OF NAIL WAS USED. FURTHER, THE KIND OF 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 AN INTRA-OPERATIVE PROCEDURE. THE CRACK THAT WAS FOUND IN THE TARGET DEVICE (COLLATERAL FINDING) WAS CAUSED DUE TO INTERNAL MATERIAL STRESSES ENFORCED BY MULTIPLE STERILIZATION PROCEDURES AND CLEANING CYCLES OVER THE YEARS OF USE. REGARDING CLEANABILITY (REF TO CLINICAL STATEMENT, DR. MUECKTER, TO 223097 AND 223094): "CONCLUSION: IT IS POSSIBLE THAT A FISSURE IN THE TARGET DEVICE WILL BE ENTERED BY BODILY FLUIDS (E.G. BLOOD, FAT, BONE MARROW). THE FISSURE GAP IS HARD TO CLEAN WITH ESTABLISHED METHODS. BUT, DUE TO THE GOOD HEAT CONDUCTIVITY OF CFC IT IS GRANTED THAT ALL CELLS IN THE FISSURE GAP ARE COMPLETELY DENATURED AND INACTIVATED. THEREFORE, THE RISK OF INFECTION OR OF ANY IMMUNOLOGIC REACTION IS NOT INCREASED EVEN IF THE FISSURE GAP IS FILLED WITH ENCRUSTED BODY FLUIDS FROM FORMER SURGICAL PROCEDURES. WHAT IS CRUCIAL IS THAT THE STERILIZATION PROCESS IS SUFFICIENT. NEVERTHELESS, A TARGETING DEVICE WITH FISSURES SHOULD BE REPLACED IMMEDIATELY DUE TO ITS REDUCED MECHANICAL FEATURES POSSIBLY CAUSING A MISDRILLING DUE TO BUCKLING OF THE DEVICE." INTERNAL LAB TEST REPORTS REVEALED THAT A DEVIATION DUE TO CRACKS DOES NOT LEAD TO INCREASED DAMAGE AT THE NAIL. THIS INDICATES THAT THE INTERLAMINAR CRACKS DO NOT CRITICALLY INFLUENCE THE TARGETING PERFORMANCE. IT WAS CONCLUDED THAT NO ACTION IN THE FIELD SHOULD BE PERFORMED. A DEVIATION REPORT WAS ISSUED FOR ROOT CAUSE INVESTIGATION REGARDING CRACKS AND DELAMINATION. THE MATERIAL OF THE CFR-ARM WAS CHANGED WITH AN ENGINEERING CHANGE NOTICE IN ORDER TO IMPROVE STIFFNESS AND RESISTANCE AGAINST CRACKING. A LAB TEST VERIFIED THE SUITABILITY OF THE NEW MATERIAL. THE INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE SHOW SEVERAL EXAMPLES OF DAMAGE AND RECOMMENDS REMOVAL OF SUCH DAMAGED PRODUCTS.

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO DRILL FOR DISTAL SCREW THOUGH GAMMA TARGETING ARM. DRILL BIT MISSED NAIL AND RESULTED IN SCREW BEING PLACED OUTSIDE OF DISTAL SCREW HOLE.

    Description of Event or Problem · 1

    SURGEON ATTEMPTED TO DRILL FOR DISTAL SCREW THOUGH GAMMA TARGETING ARM. DRILL BIT MISSED NAIL AND RESULTED IN SCREW BEING PLACED OUTSIDE OF DISTAL SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352626 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER TRAUMA KIEL KP235781

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other