BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02351

    MDR report key: 3093284 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02351
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 DISTAL RADIUS FRACTURE SURGERY ON (B)(6) 2013, THE SURGEON REDUCED THE FRACTURE AND PLACED K-WIRE FIXATION. AFTER THE SURGEON REPOSITIONED AND IMPLANTED THE PLATE, THE SURGEON CHOSE FIX MODE IN A POSITIONING HOLE. HE THEN INSERTED AND LOCKED THE SCREWS IN EACH HOLE. REPORTEDLY WHEN HE WAS INSERTING AND LOCKING THE SCREW IN THE DISTAL HOLE IN THE DISTAL ROW, MOST ULNA HOLE, THE SCREW PENETRATED THROUGH THE HOLE. THE SURGEON THEN REPLACED THE PLATE WITH A NEW PLATE AND COMPLETED THE PROCEDURE. IT WAS REPORTED THE SURGEON COMPLETED THE SURGERY USING THE GLOBAL TECHNICAL PROCEDURE, HE CHOSE FIXED MODE AND DID USE A TORQUE LIMITER (0.8NM) IN LOCK. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195887 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1