BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR 2.4 SELF-TAP L16 TAN

    MDR report key: 2944867 · Received February 6, 2013

    Report

    Report Number
    1719045-2013-00261
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 1, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SINGLE SCREW WAS RECEIVED WITH THE SUBTASK RELATED TO THIS COMPLAINT. IT IS WHOLE AND INTACT. THE DIAMETER, LENGTH, AND GENERAL CONFIGURATION CONFIRM IT WAS BEING AN 04.210.116. THE DRIVE HAS SUSTAINED MODERATE TO HEAVY DAMAGE, PRIMARILY TOWARDS THE TOP OF THE DRIVE. THE TOP OF THE HEAD HAS NUMEROUS LIGHT TO MODERATE MARKS. BOTH THREAD LEADS HAVE THE STARTS REMOVED AND ALSO HAVE THREAD DEFORMATION UPWARDS. ONE HEAD THREAD HAS BEEN COMPRESSED SIGNIFICANTLY AT THE MAJOR DIAMETER. THE SHAFT THREADS ARE IN GOOD CONDITION WITH THE EXCEPTION THAT THERE ARE SOME MINOR DENTS, SOME WITH MATERIAL DISPLACEMENT, AT THE MAJOR DIAMETER AT THE LAST SEVEN THREADS. THE FLUTES AND THE TIP ARE IN GOOD CONDITION. THE RELEVANT DIMENSIONS THAT COULD BE CHECKED ARE WITHIN SPECIFICATION. DUE TO THE TYPE OF DAMAGE INCURRED, A FINITE EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012, SURGEON WAS PERFORMING SURGERY FOR A DISTAL RADIUS FRACTURE. AFTER RE-POSITIONING AND INSTALLING THE PLATE, SURGEON DRILLED THE BONE THROUGH THE GUIDING BLOCK AND QUICK DRILL SLEEVE. NEXT, SURGEON INSERTED A VA LOCKING SCREW THROUGH THE GUIDING BLOCK IN THE POSITIONING HOLE. WHEN SURGEON INSERTED THE VA LOCKING SCREW IN THE PROXIMAL ROW STYLOID HOLE, INSERTION FELT ABNORMAL AND SURGEON FOUND THAT THE SCREW WAS NOT LOCKED AND WAS PENETRATING IN THE HOLE. SURGEON REMOVED THE SCREW FROM THE DORSAL SIDE, BUT LEFT THE PLATE IN THE PATIENT. AFTER THIS, SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING A NEW SCREW AND A TORQUE LIMITER. IT IS REPORTED THAT THE SURGEON IS A WOMAN SO SHE DOES NOT THINK SHE WAS STRONG ENOUGH TO OVER TORQUE THE SCREW. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50375 VA LOCKSCR 2.4 SELF-TAP L16 TAN SELF-TAP LOCKING SCREW HWC SYNTHES MONUMENT 8079903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention