BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1719045-2013-00644

    MDR report key: 3011347 · Received March 19, 2013

    Report

    Report Number
    1719045-2013-00644
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    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. 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. SURGEON INSERTED A TOTAL OF SIX SCREWS AS FOLLOWS: 04.210.114S ,LOT 7918191; 04.210.112S, LOT 8100666; 04.210.116S, LOT 8159846; AND THREE 04.210.118S FROM LOTS 8047598, 8137213, AND 8163386. THE SCREW THAT PENETRATED THE PLATE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUFFERED FROM FRACTURE OF THE DISTAL RADIUS. PATIENT WAS IMPLANTED WITH VA LCP 2 COLUMN DRP2.4 VOLAR NARROW PLATE AND SIX VA LOCKING SCREWS ON (B)(6) 2013. WHEN SURGEON WAS INSERTING THE MOST DISTAL SCREW WHILE USING A GUIDE BLOCK, THE VA LCP WOULD NOT LOCK. SURGEON INSERTED THE SCREW LOCATED IN THE SECOND LINE OF THE DISTAL SIDE AND DECIDED THERE WERE NO PROBLEMS AND THE PROCEDURE WAS COMPLETED. SURGEON CHECKED X-RAY IMAGES, AND FOUND THAT THE MOST DISTAL SCREW PENETRATED THE PLATE. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113228 HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1