BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR WITH HANDLE FOR USE WITH 03.120.014

    MDR report key: 3091578 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02093
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT BACK THEN THE NCR 105087 WAS OPENED BECAUSE A DISCREPANCY AT THE DRAWING, COMPARED WITH ANOTHER PART, WAS DETECTED. THIS NCR HAD NO INFLUENCE ON THE FUNCTIONALITY OF THE INSTRUMENT. NO COMPLAINT RELATED ISSUE COULD BE DETECTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED DEVICE WAS ASSEMBLED WITH A KNOWN GOOD MATING PART 03.120.014, LOT 1766553, LOCKING NEUTRAL GUIDE, DURING THIS EVALUATION. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. THE RETURNED TROCAR WITH HANDLE DID NOT LOCK AND RETAIN THE LOCKING NEUTRAL GUIDE WHEN INSERTED. THE FLAT CANTILEVER RELEASE SPRING IS SLIGHTLY DEPRESSED IN THE TROCAR BODY AND NO LONGER FUNCTIONS AS INTENDED. THE RELEASE SPRING PORTION, PART 03.120.015.01 WAS MANUFACTURED FROM 17-4PH SS WHICH IS A TYPICAL MATERIAL USED FOR THIS APPLICATION AND IS HEAT TREATED TO H900 PER ES0052 TO IMPROVE WEAR RESISTANCE. THE RELEASE SPRING IS LASER WELDED TO THE TROCAR BODY, PART 03.120.015.02, WHICH IS ALSO HEAT TREATED 17-4PH SS MATERIAL. THE WELD IS STILL INTACT ON THE RETURNED DEVICE. THE DESIGN WAS REVIEWED, IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS IS THE ONLY COMPLAINT FOR THIS CONDITION OF BROKE IN THE ENTIRE COMPLAINT HISTORY FOR TROCAR PART 03.120.015 AND APPROXIMATELY 840 HAVE BEEN DISTRIBUTED SINCE RELEASE WHICH RESULTS IN AN ESTIMATED COMPLAINT RATE OF 0.12 PERCENT BASED ON SALES. THE BEND LINE ON THE RELEASE SPRING ON THE RETURNED DEVICE IS NOT A RESULT OF NORMAL USE WITH MATING PART, LOCKING NEUTRAL GUIDE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE. PLACEHOLDER.

    Description of Event or Problem · 1

    A TROCAR WAS REPORTED AS NOT FUNCTIONING CORRECTLY DURING A SURGERY FOR A PLATING OF A DISTAL FEMORAL FRACTURE ON (B)(6) 2013. IT WAS REPORTED THAT EITHER THE MAIN MECHANISM OR SPRING WAS BROKEN. THE SURGEON WAS ABLE TO USE THE TROCAR BUT IT WAS CUMBERSOME DUE TO THE BROKEN MECHANISM. IT WAS REPORTED THAT ANOTHER OPTION WAS NOT AVAILABLE. THE SURGERY WAS PROLONGED LESS THAN TWO MINUTES. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193714 TROCAR WITH HANDLE FOR USE WITH 03.120.014 FZX SYNTHES GMBH 1972435

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR