BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION/DISTRACTOR ROD F/LOCK HOLE Ø2.7

    MDR report key: 3191499 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03747
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWN
    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 COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: COMPRESSION DISTRACTION ROD FOR LOCKING HOLE Ø 2.7 MM IS DIFFICULT TO SCREW INTO THE PLATE, BECAUSE THE ZERO ANGLE IS HARD TO FIND WITHOUT ANY ADDITIONAL HELP OF ANOTHER INSTRUMENT. SURGEON HAD TO TAKE THE DRILL SLEEVE TO FIND THE ZERO ANGLE AND CONTINUED TO EXPERIENCE DIFFICULTY INSERTING THE SCREW INTO THE PLATE. IN ADDITION, THE RECESS APPEARS AS IF IT IS NOT DEEP ENOUGH AND THE STARDRIVE SCREW DRIVER DOES NOT HOLD. THESE EVENTS PROLONGED THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290302 COMPRESSION/DISTRACTOR ROD F/LOCK HOLE Ø2.7 HWN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1