BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 2920774 · Received January 17, 2013

    Report

    Report Number
    1719045-2013-00142
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED SCREW WAS FORWARDED TO THE RESPONSIBLE PRODUCT DEVELOPMENT MANAGER. THE RESULT; THE SCREW SHOW A DEFORMATION OF SCREW HEAD THREAD AND DRIVE. THE THREAD IS COMPLETELY WORN OUT AND A FUNCTION IS NOT GIVEN ANY MORE. THE POINTED OUT DEFORMATION OF THE HEAD THREAD RESULTED DUE TO CONTACT TO THE PLATE THREAD. NO MANUFACTURING RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING SURGERY FOR A DISTAL RADIUS FRACTURE. IT WAS REPORTED THAT THE SURGEON PRE-FIXED THE PLATE AT THE DISTAL, MOST ULNAR AND SHAFT SIDE HOLES, USING K-WIRE. HE INSERTED AND LOCKED VA LOCKING SCREWS THROUGH THE GUIDING BLOCK IN THE DISTAL ROW HOLE. HE INSERTED AND LOCKED THE VA LOCKING SCREW IN THE DISTAL ROW, MOST STYLOID HOLE BY VA MODE. HE THEN REMOVED THE PLATE AND SCREWS AND NOTED A POSSIBLE SMALL BREAKAGE OF THE PLATE, FOLLOWING THE REMOVAL OF THE K-WIRES. UPON RE-INSERTION OF THE HARDWARE, THE VA LOCKING SCREW L16 DID NOT LOCK IN THE DISTAL ROW, MOST STYLOID HOLE OF THE PLATE AND PENETRATED THE PLATE. THE SURGEON INSERTED A NEW SCREW AND NEW PLATE AND COMPLETED THE PROCEDURE. AFTER THE SURGERY, THE SURGEON FOUND THAT THE L16 STILL WOULD NOT LOCK IN THE PLATE THAT WAS NOT IMPLANTED HOWEVER, THE L18 SCREW DID LOCK WITH THE USE OF A TORQUE LIMITER. THIS IS REPORT # 2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25953 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN VA LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR