BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 3071113 · Received April 22, 2013

    Report

    Report Number
    0009610622-2013-00217
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION REVEALED THE TARGET DEVICE TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. 7 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. THE FOUND CRACKS AT THE TARGET DEVICE WERE MOST LIKELY DUE TO INTERNAL MATERIAL STRESSES ENFORCED BY MULTIPLE STERILIZATION PROCEDURES AND CLEANING CYCLES OVER THE YEARS OF USE. ALTHOUGH CRACKED THE TARGET DEVICE DID PASS THE PRE-OPERATIVE CHECK. REGARDING CLEANABILITY (REF TO CLINICAL STATEMENT): ¿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 REPORTS 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. IT WAS CONCLUDED THAT NO ACTION IN THE MARKET SHOULD BE PERFORMED. A DEVIATION REPORT WAS ALREADY ISSUED FOR ROOT CAUSE INVESTIGATION REGARDING CRACKS RESP. DELAMINATION. THE MATERIAL OF THE CFR-ARM HAS ALREADY BEEN CHANGED IN ORDER TO IMPROVE STIFFNESS AND RESISTANCE AGAINST CRACKING. LAB TEST HAD VERIFIED THE SUITABILITY OF THE NEW MATERIAL. THE BROCHURE INSTRUCTIONS FOR CLEANING, STERILIZATION, INSPECTION AND MAINTENANCE SHOWS SEVERAL EXAMPLES OF DAMAGES AND RECOMMENDS REMOVING OF SUCH DAMAGED PRODUCTS. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    CURRENTLY THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT DURING A SURGICAL PROCEDURE SHE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH THE TARGET DEVICE. IT WAS OBSERVED THAT THE TARGET BOW WAS DISTORTED AND HENCE, THE SLEEVE DIDN'T FIT TO THE DEVICE ANYMORE AND THIS RESULTS IN FAIL DRILLINGS.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT DURING A SURGICAL PROCEDURE SHE OBSERVED THAT THE SURGEON HAD PROBLEMS WITH THE TARGET DEVICE. IT WAS OBSERVED THAT THE TARGET BOW WAS DISTORTED AND HENCE, THE SLEEVE DIDN'T FIT TO THE DEVICE ANYMORE AND THIS RESULTS IN FAIL DRILLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172616 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KME901333

    Patients

    Seq Age Sex Outcome Treatment
    1