BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

    MDR report key: 3093285 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02349
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    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

    THE DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. THE COMPLAINED ARTICLES WERE SENT TO OUR PRODUCT MANAGER FOR TESTING AND INVESTIGATION; HERE THE FEEDBACK. THE HEAD THREAD OF THE SCREW IS BADLY DAMAGED. THE ENTIRE THREAD IS WORN OUT AND CRUSHED TOGETHER. THE STAR DRIVE IS DAMAGED TOO. BY THE PLATE THERE WE DISCOVERED DAMAGED THREADS. SOME PITCHES OF THE THREAD ARE COMPLETELY WORN AWAY. THEREFORE WE ASSUME THAT THE SCREW WAS SCREWED INTO THE PLATE WITH AN OVERLOAD OF FORCE, WHICH RESULTED TO THE PENETRATION OF THE HOLE AND THE DAMAGE ON THE SCREW. WE COULD NOT FIND ANY DEVIATION TO OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING DISTAL RADIUS FRACTURE SURGERY ON (B)(6) 2013, THE SURGEON REDUCED THE FRACTURE AND PLACED K-WIRE FIXATION. AFTER THE SURGEON REPOSITIONED AND IMPLANTED THE PLATE, THE SURGEON CHOSE FIX MODE IN A POSITIONING HOLE. HE THEN INSERTED AND LOCKED THE SCREWS IN EACH HOLE. REPORTEDLY WHEN HE WAS INSERTING AND LOCKING THE SCREW IN THE DISTAL HOLE IN THE DISTAL ROW, MOST ULNA HOLE, THE SCREW PENETRATED THROUGH THE HOLE. THE SURGEON THEN REPLACED THE PLATE WITH A NEW PLATE AND COMPLETED THE PROCEDURE. IT WAS REPORTED THE SURGEON COMPLETED THE SURGERY USING THE GLOBAL TECHNICAL PROCEDURE, HE CHOSE FIXED MODE AND DID USE A TORQUE LIMITER (0.8NM) IN LOCK. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196368 VA LOCKSCR Ø2.4 SELF-TAP L12 TAN HWC SYNTHES USA 8100666

    Patients

    Seq Age Sex Outcome Treatment
    1