BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 2944408 · Received February 5, 2013

    Report

    Report Number
    1719045-2013-00229
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 7, 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 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 WITH THE PLATE THREAD. WE ASSUME THAT THE DAMAGE ON THE DRIVE RESULTED DUE THE CONTACT WITH THE SCREWDRIVER. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLEASE DO ALWAYS FOLLOW THE INSTRUCTIONS DESCRIBED AT THE TECHNIQUE GUIDE.

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

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE THE SURGEON DRILLED A LOCKING SCREW THROUGH A PLATE. THE SURGEON FIXED THE K-WIRE AND THEN DRILLED BONE THROUGH A GUIDING BLOCK AND QUICK DRILL SLEEVE. HE THEN SLOWLY INSERTED AND LOCKED THE VA LOCKING SCREW THROUGH THE GUIDING BLOCK IN A POSITIONING HOLE. HE COULD NOT LOCK THE SCREW IN THE MOST DISTAL STYLOID HOLE. THE SURGEON CONFIRMED THE POSITION OF THE SCREW VIA IMAGING AND NOTED THE SCREW PENETRATED THE HOLE. HE REMOVED THE PENETRATION SCREW FROM THE OPPOSITE END BUT LEFT THE PLATE IN PLACE. THIS WAS A NEW SURGICAL PROCESS WHICH UTILIZED A FIXED MODE TECHNIQUE. FOR THE PROCEDURE HE USED THE TORQUE LIMITER IN THE LOCK, AS OPPOSE TO USING A POWER TOOL. OVERALL, THE SURGEON USED A GUIDING BLOCK, QUICK DRILL SLEEVE AND TORQUE LIMITER BY FIXED MODE WHICH RESULTED IN THE LOCKING SCREW PENETRATING THE PLATE AND LEAVING A METAL CIRCLE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47675 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN LOCKING SCREW HWC SYNTHES MONUMENT 7847742

    Patients

    Seq Age Sex Outcome Treatment
    1