BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR 2.4 SELF-TAP L16 TAN

    MDR report key: 2954921 · Received February 11, 2013

    Report

    Report Number
    1719045-2013-00264
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 3, 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. A 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 SLIGHT MARKINGS CONSISTENT WITH USE. THE TOP OF THE HEAD HAS NUMEROUS LIGHT SCRATCHES, MARKS. ONE THREAD AT THE HEAD THREAD JUNCTURE APPEARS TO HAVE BEEN BROKEN OFF. THE THREAD AT THE OPPOSITE SIDE OF THE HEAD HAS BEEN BENT UPWARDS SLIGHTLY. THE HEAD THREADS HAVE BEEN COMPRESSED AT THE MAJOR DIAMETER. MOST OF THE FINISH HAS BEEN REMOVED IN THIS AREA. THE SHAFT THREADS ARE IN GOOD CONDITION, AS ARE THE FLUTES AND THE TIP. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012 SURGEON WAS PERFORMING A PROCEDURE FOR A DISTAL RADIUS FRACTURE. AFTER RE-POSITIONING AND INSTALLING THE PLATE, THE SURGEON DRILLED THROUGH THE GUIDING BLOCK AND QUICK DRILL SLEEVE. NEXT, HE INSERTED A LOCKING SCREW THROUGH THE GUIDING BLOCK AND LOCKED THE VA LOCKING SCREW IN THE DISTAL ROW ULNA HOLE. IT IS REPORTED THAT THE INSERTION FELT ABNORMAL TO THE SURGEON. SURGEON NOTICED THAT THE SCREW WAS NOT LOCKED AND HAD PENETRATED THROUGH THE HOLE OF THE PLATE. SURGEON HAD TO REMOVE PLATE AND ALL OTHER SCREWS IN ORDER TO GET THE SCREW OUT, BECAUSE IT WOULD NOT COME OUT THROUGH THE HOLE. SURGEON RE-INSERTED THE PLATE AND HARDWARE WITHOUT THE LOCKING SCREW THAT PENETRATED THROUGH THE PLATE. HE CHOSE TO USE A TORQUE LIMITER, AND PROCEDURE WAS COMPLETED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59104 VA LOCKSCR 2.4 SELF-TAP L16 TAN LOCKING SCREW HWC SYNTHES MONUMENT 8100676

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention