BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL CHUCK WITH T-HANDLE

    MDR report key: 3212859 · Received July 9, 2013

    Report

    Report Number
    8030965-2013-04257
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. AN ADDITIONAL EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH THE HANDLE FALLING APART. THE INVESTIGATION HAVE SHOWN THAT THE COMPLETE UNIVERSAL CHUCK IS DISMANTLED. THIS IS LIKELY DUE TO REPROCESSING CARE MAINTENANCE. THE MANUAL PRE-CLEANING INCLUDES ULTRASONIC CLEANING; THIS ALLOWS EFFECTIVE CLEANING AND REPROCESSING ARE GUARANTEED WITH STEAM STERILIZATION. THIS DEVICE IS OVER 13 YEARS OLD (IT WAS MADE IN MARCH 2000) AND IT CANNOT BE DETERMINED HOW THE DEVICE WAS CONTAMINATED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THE HANDLE WAS DEFECTIVE AND FELL APART DURING A PROCEDURE ON AN UNKNOWN DATE, CAUSING IT TO BE CONTAMINATED BY DIRT AND MUD, AND WAS VERY CRITICAL. REPORTEDLY IN THE PREPARATION INFORMATION THERE IS NOT ANY NOTE THAT THIS INSTRUMENT SHOULD BE DISASSEMBLED BEFORE CLEANING AND THE FACILITY FELT THAT THIS INSTRUMENT WOULD ALWAYS BE CONTAMINATED AS A RESULT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314339 UNIVERSAL CHUCK WITH T-HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH 1053304

    Patients

    Seq Age Sex Outcome Treatment
    1