BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    MDR report key: 3003749 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-00860
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    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. (B)(4). A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: TIGHTENING TORQUE DID NOT WORK. ON (B)(6) 2013 A (B)(6) FEMALE PATIENT UNDERWENT SURGERY TO REPAIR A FRACTURE OF THE LEFT DISTAL RADIUS. DURING THE PROCEDURE THE DISTAL LOCKING SCREW PENETRATED THE FRACTURED DISTAL RADIUS. THE PLATE WAS ATTACHED WITH A GUIDING BLOCK TO THE KIRSCHNER WIRE AND ELLIPSOIDAL HOLE BY USE OF CORTSCR DIAMETER 2.7. THE SURGEON MADE A SKIN INCISION FOLLOWED BY MANIPULATION AND TEMPORARILY FIXATION OF THE KIRSCHNER WIRE ON THE FRACTURE OF THE LEFT DISTAL RADIUS. FOR THE MOST DISTAL POSITION, THE SURGEON INSERTED THE SCREW WITH THE FIXATION MODE. THE SCREWS WERE INSERTED RADIALWARD BUT THE SCREW TIGHTENING TORQUE OF THE DRIVER DID NOT WORK. AS A RESULT, THE SURGEON COULD NOT SEE AN IMAGE IN THE OPERATIVE FIELD. AFTER THE BLOCK ATTACHED TO THE PLATE WAS REMOVED, THE DOCTOR NOTED THE PENETRATION BY THE SCREW WITH NO TORQUE. AFTER THE RECOVERY OF THE REMOVED SCREW, THE VA LCP 2 COLUMN REMAINED INSIDE THE PATIENTS ARM AND WILL BE RECOVERED AFTER THE REMOVAL FOR THE FOLLOWING REASONS: THE FIXATION OF THE PLATE WAS COMPLETED AND PER THE DOCTOR THERE WAS NO PROBLEM WITHOUT THE SCREW. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107941 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA HRS SYNTHES GMBH 8181906

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR