BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S

    MDR report key: 2981705 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00665
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PERFORMED INVESTIGATION HAS SHOWN THAT THE TIP AT THE END OF THE ALLEN WRENCH HAS BROKEN OFF. THE ALLEN WRENCH ALSO SHOWS SIGNS OF WEAR. UNFORTUNATELY WE CAN NOT UNDERSTAND THE EXACT REASON FOR THIS OVERLOAD AFTERWARDS. THE FRACTURE SURFACE IS HOMOGENEOUS WHAT INDICATES A PROPER MATERIAL QUALITY. A NEW SOLUTION TO THE COMPLAINED ALLEN WRENCH WOULD BE THE NEWLY DEVELOPED HOLDING SLEEVE FOR PEDICLE SCREWS PART NO 314.069. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE PIN AT THE END OF THE SCREWDRIVER IS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84474 SCR-DRIVER-HEX Ø3.5 W/T-HANDLE F/PEDIC S SCREWDRIVER HXX SYNTHES GMBH 8058777

    Patients

    Seq Age Sex Outcome Treatment
    1