BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T15 STD

    MDR report key: 3233816 · Received July 18, 2013

    Report

    Report Number
    8030965-2013-04396
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 28, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A REVISION SURGERY ON (B)(6) 2013, THE SURGEON TRIED TO OPEN A MATRIX TRANSCONNECTOR WITH THE TORQUE HANDLE AND THE SCREW DRIVER SHAFT TO GAIN ACCESS FOR DECOMPRESSION. HE HEARD A CLACK SOUND AND REMOVED THE INSTRUMENT. THE TIP OF THE SCREW DRIVER SHAFT WAS BROKEN OFF AND THE SCREW WAS STILL TIGHT. HE REMOVED ALL INSTRUMENT PARTS FROM THE PATIENT AND HAD TO DO THE DECOMPRESSION WITH THE TRANS-CONNECTOR IN PLACE. THE SURGEON MENTIONED THAT HE INSTALLED THE TRANSCONNECTOR IN THE FIRST PLACE AND IS ABSOLUTELY SURE THAT HE USED THE TORQUE HANDLE TO TIGHTEN THE TRANSCONNECTOR WITH THE CORRECT TORQUE. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333922 SCRDRIVERSHAFT T15 STD HXX SYNTHES GMBH 8194284

    Patients

    Seq Age Sex Outcome Treatment
    1