BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L14 TAN

    MDR report key: 3110923 · Received May 14, 2013

    Report

    Report Number
    1719045-2013-01430
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    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

    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION OF THE COMPLAINED LOCKING SCREW SHOWS THAT THE HEAD LOCKING THREAD IS BADLY DEFORMED. WE COULD NOT DEFINE THE EXACT ROOT CAUSE OF THIS COMPLAINED ARTICLE. WE HAVE TO ASSUME THAT THIS DAMAGE OCCURRED DUE EXCEEDING APPLIED MECHANICAL FORCE WHILE INSERTION. THE SCREW HEAD IS DEFORMED IN SUCH A CASE AS HE COULD SLIP THROUGH THE PLATE FINALLY. THE MENTIONED PLATE WAS NOT SENT FOR INVESTIGATION. NO PRODUCT FAULT COULD BE DETECTED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE SURGEON CHOSE VARIABLE ANGLE (VA) MODE FOR THE SURGERY. THE SURGEON INSERTED THE 2.7MM CORT. SCREW IN THE PROXIMAL HOLE. HE THEN INSERTED THE VA LOCKING SCREW IN THE DISTAL HOLE. REPORTEDLY THE SURGEON CONTINUED TO ROTATE THE DRIVER; HOWEVER, HE DID NOT FEEL THE SCREW LOCKED IN THE DISTAL ROW, MOST ULNA SIDE. HE INSERTED THE OTHER TWO SCREWS IN THE OTHER DISTAL HOLES AND THE 2.7MM CORT. SCREW IN THE PROXIMAL HOLE. THE SURGEON LOCKED THE SCREWS AND HE CONFIRMED TORQUE THROUGH THE DISTAL ROW, MOST ULNA HOLE. IT WAS REPORTED THE SURGEON TRIED TO INSERT THE SAME LENGTH VA SCREW IN THE DISTAL ROW, MOST ULNA HOLE, BUT THE SCREW TORQUE THROUGH. THE SURGEON THEN CHANGED THE PROCEDURE FROM VA TO FIX MODE. REPORTEDLY THE SURGEON INSERTED THE 2.4MM VA LOCKING SCREW AND THE SCREW COULD NOT BE LOCKED IN THE DISTAL ROW, MOST ULNA HOLE. HE WANTED TO INSERT A 2.4MM CORT. SCREW, SO THE SURGEON REMOVED THE VA SCREW AND INSERTED THE 2.4MM CORT. SCREW. THE SURGEON INSERTED ONE OF TWO SCREW AND TORQUE THROUGH THE DISTAL ROW, SECOND ULNA HOLE BY VA MODE. AS A RESULT, HE WAS ABLE TO LOCK THE SCREW. IT WAS REPORTED THE SURGEON USED THE TORQUE LIMITER 0.8NM IN LOCK. THE PLATE AND ONE OF THE TWO SCREWS THAT TORQUE THROUGH ARE IMPLANTED IN THE PATIENT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213032 VA LOCKSCR Ø2.4 SELF-TAP L14 TAN HWC SYNTHES MONUMENT 8271698

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR