BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 LONG F/MATRIX

    MDR report key: 3140267 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-03003
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES USA
    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. THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.(B)(4)

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE SURGEON IMPLANTED THE PATIENT MATRIX MINIMALLY INVASIVE SPINE SYSTEM. THE SURGEON PERFORMED A FINAL TIGHTENING OF ALL THE CAPS. THREE OF SIX CAPS COLD WELDED. THE TORQUE LIMITER WAS USED TO FINAL TIGHTEN. HE TRIED ALL THE TECHNIQUES SUGGESTED WITHOUT SUCCESS. BOTH TIPS OF THE SCREWDRIVER SHAFTS COMPLETELY BROKE OFF. THE TIPS WHICH BROKE OFF WERE REMOVED AND DISCARDED. THE SURGEON WANTED TO LOOSEN THE LOCKING CAPS IN ORDER TO SLIDE THE ROD DOWN INTO A BETTER POSITION. THE SURGEON DECIDED TO LEAVE IT AS IT WAS. SURGEON WAS NOT HAPPY AT ALL WITH THE OUTCOME. SCREWDRIVERS WERE THROWN OUT AS THEY WERE CONTAMINATED. A DELAY OF ABOUT 10 MINUTES WAS ADDED TO THE PROCEDURE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242037 SCRDRIVERSHAFT T25 LONG F/MATRIX HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1