BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 2924674 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00163
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. THE COMPLAINED VA LOCKING SCREW WAS FORWARDED TO THE RESPONSIBLE PRODUCT DEVELOPMENT MANAGER. THE RESULT, THE SCREW SHOWS A DEFORMATION OF SCREW HEAD THREAD AND DRIVE. THIS POINTED OUT DEFORMATION OF THE HEAD THREAD RESULTED DUE THE CONTACT TO THE PLATE THREAD. WE ASSUME THAT THE DAMAGE ON THE DRIVE RESULTED OUT OF THE CONTACT WITH THE SCREWDRIVER. NO PRODUCT FAULT COULD BE DETECTED.

    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 REPOSITIONING AND INSTALLING THE VA LCP PLATE, THE SURGEON DRILLED BONE THROUGH GUIDING BLOCK AND QUICK DRILL SLEEVE. SURGEON INSERTED THE VA LOCKING SCREW THROUGH THE GUIDE BLOCK INTO THE DISTAL ROW STYLOID HOLE. SOMETHING FELT ABNORMAL AND SURGEON FOUND THE SCREW DID NOT LOCK INTO THE HOLE, BUT WENT THROUGH THE HOLE. SURGEON HAD TO CUT THE PATIENT AND REMOVE THE SCREW FROM THE DORSAL SIDE. THE PROCEDURE WAS COMPLETED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29601 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN VA LOCKSCREW HWC SYNTHES MONUMENT 8114056

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SCREW, PLATE