BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3®

    MDR report key: 5011188 · Received August 18, 2015

    Report

    Report Number
    0009610622-2015-00398
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540716774
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 OLD 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 ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS IT HAD BEEN IN USE FOR A LONGER TIME (MORE THAN 9 YEARS) WE PRE-SUPPOSE THAT THIS TARGET DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THE RETURNED TARGET DEVICE DID NOT PASS THE PRE-OPERATIVE FUNCTION TEST AS INTENDED. PROXIMAL ¿ AND DISTAL MISTARGETING COULD BE CONFIRMED. 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. REGARDING MISDRILLING THE OPERATIVE TECHNIQUE HAS ALREADY 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 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. THE ALLEGED EVENT IS CAUSED DUE TO USING A NOT FUNCTIONAL VERY OLD TARGET DEVICE. THIS IS REGARDED AS NOT DEVICE ¿ BUT USER RELATED. THE IMPACTS FOUND IN THE CFR-MATERIAL ARE DUE ARE DUE TO HAMMERING WHICH IS ALSO REGARDED AS USER RELATED. THE FOUND CRACKS IN THE TARGET DEVICE WERE 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. (B)(6), TO 223097 AND 223094): ¿CONCLUSION: IT IS POSSIBLE THAT A FISSURE IN THE TARGET DEVICE WILL BE ENTERED BY BODY FLUIDS (E.G. BLOOD, FAT, BONE MARROW). THE FISSURE GAP IS HARDLY 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 MISDRILL DUE TO BUCKLING OF THE DEVICE.¿ INTERNAL LAB TEST REPORT 241007CB1 AND 010208CB1 REVEALED THAT DEVIATION DUE TO CRACKS DOES NOT LEAD TO INCREASED DAMAGES AT THE NAIL. THIS INDICATES THAT THE INTERLAMINAR CRACKS DO NOT INFLUENCE THE TARGETING PERFORMANCE CRITICALLY. REFERRING TO COMPILED HAT 392-42801 IT WAS CONCLUDED THAT NO ACTION IN THE MARKET SHOULD BE PERFORMED. DEVIATION REPORT 548/05 WAS ALREADY ISSUED FOR ROOT CAUSE INVESTIGATION REGARDING CRACKS RESP. DELAMINATION. WITH ENGINEERING CHANGE NOTICE ECN 6053/07 THE MATERIAL OF THE CFR-ARM HAS ALREADY BEEN CHANGED IN ORDER TO IMPROVE STIFFNESS AND RESISTANCE AGAINST CRACKING. LAB TEST 081107CB1 HAD VERIFIED THE SUITABILITY OF THE NEW MATERIAL. THE BROCHURE INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE (L240020009) SHOWS SEVERAL EXAMPLES OF DAMAGES AND RECOMMENDS REMOVING OF SUCH DAMAGED PRODUCTS. MEANWHILE THE PRODUCT HAS BEEN MODIFIED WITH ECN 6053/07 IN TERMS MATERIAL CHANGE IN ORDER TO AVOID CRACKS AND TO IMPROVE STIFFNESS.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. WAS USING THE GAMMA3 TARGETING ARM IN A CASE AND SOME OF THE ADDITIONAL PIECES WERE NOT LINING UP DURING THE PROCEDURE. THE LAG SCREW KWIRE WAS AIMING SUPERIOR IN THE LAG SCREW HOLE DURING INITIAL PLACEMENT OF THE LAG SCREW. DURING INSERTION OF THE DISTAL LOCKING SCREW USING THE TARGETER, IT WAS DETERMINED UNDER X-RAY THAT THE SCREW MISSED THE HOLE AND WAS ANTERIOR TO THE NAIL. THE SURGEON THEN HAD TO USE X-RAY TO MAKE SURE THE SCREW WAS IN THE NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. WAS USING THE GAMMA3 TARGETING ARM IN A CASE AND SOME OF THE ADDITIONAL PIECES WERE NOT LINING UP DURING THE PROCEDURE. THE LAG SCREW KWIRE WAS AIMING SUPERIOR IN THE LAG SCREW HOLE DURING INITIAL PLACEMENT OF THE LAG SCREW. DURING INSERTION OF THE DISTAL LOCKING SCREW USING THE TARGETER, IT WAS DETERMINED UNDER X-RAY THAT THE SCREW MISSED THE HOLE AND WAS ANTERIOR TO THE NAIL. THE SURGEON THEN HAD TO USE X-RAY TO MAKE SURE THE SCREW WAS IN THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544987 TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL KP237385 04546540716774

    Patients

    Seq Age Sex Outcome Treatment
    1 Other