BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02176

    MDR report key: 3081448 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02176
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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. CATALOG #: THE CATALOG NUMBER CANNOT BE CONFIRMED; HOWEVER, THE SCREW IS WITHIN THE PART FAMILY OF 04.210.1XXS. 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

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A DISTAL RADIUS FRACTURE SURGERY ON (B)(6) 2013, AFTER REPOSITIONING AND IMPLANTING THE VA LCP 2 COLUMN DISTAL RADIUS PLATE, THE SURGEON THEN INSERTED AND LOCKED THE VA LOCKING SCREWS. IT WAS REPORTED THE SURGEON FELT THE SCREW WAS NOT LOCKED IN THE DISTAL ROW, MOST STYLOID HOLE. IMAGES TAKEN REVEALED THE SCREW WAS PENETRATED. THE SURGEON COULD REMOVE THE SCREW THROUGH THE PLATE HOLE AND DECIDED TO LEAVE THE PENETRATED SCREW AND PLATE IMPLANTED. THE SURGERY WAS COMPLETED. REPORTEDLY THE SURGEON COMPLETED THE PROCEDURE BY THE GLOBAL TECHNICAL PROCEDURE, HE CHOSE FIXED MODE AND USED THE TORQUE LIMITER 0.8NM IN LOCK. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185671 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1