BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S

    MDR report key: 2870516 · Received December 12, 2012

    Report

    Report Number
    8030965-2012-01564
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 14, 2012
    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 USED FOR TREATMENT AND 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

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING SURGERY FOR A DISTAL RADIUS FRACTURE, AFTER SUCCESSFULLY INSERTING FOUR VA SCREWS USING A GUIDING BLOCK AND A TORQUE DRIVER AT A PERIPHERAL PART, WHEN THE SURGEON WAS INSERTING ANOTHER VA SCREW, PROBABLY 12MM ONE, INTO A HOLE IN THE SECOND ROW AT THE RADIUS SIDE, IT WENT DEEPER THAN USUAL, AS HE FELT THAT THE ANGLE OF THE SCREW HAD BEEN CHANGED WHILE THE TORQUE DRIVER WAS GOING TO BE IDLED. SURGEON TRIED TO REMOVE THE SCREW IN A USUAL WAY BUT COULD NOT DO IT. SURGEON EVENTUALLY REMOVED IT WHILE HE MESHED THE SCREW WITH THE DRIVER AT AN ANGLE TO THE PLATE OR THE BONE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S VA-LCP-2-COLUMN PLATE HRS SYNTHES GMBH 7755185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PLATE, SCREW