BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.3.5MM SELF DRILLING 10MM

    MDR report key: 2935004 · Received January 30, 2013

    Report

    Report Number
    0009617544-2013-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY. RESULTS: NO DEVICE WAS RETURNED. IT WAS MENTIONED THAT THE SCREW AND RING WERE DISPOSED OF BEFORE SALES REP WAS ABLE TO RECOVER THEM. NO MEASUREMENT AND VISUAL INSPECTION UNDER BINOCULAR CAN BE PERFORMED FOR ANALYSIS. THE REVIEW OF THE PER DATABASE WAS PERFORMED FROM (B)(6) 2011 (ANCHOR C PRODUCT BRAND WAS LAUNCH IN (B)(6) 2011) TO (B)(6) 2013. ALL CATALOGUES NUMBERS OF SCREWS WERE INCLUDED INTO THE SEARCH (REFER TO LISTING IN SURGICAL TECHNIQUE). AS A RESULT 6 CONFIRMED PERS WERE REPORTED IN SUPER AND ONE (THIS ONE) IN TRACKWISE. INVESTIGATIONS DURING PREVIOUS CASES HAD POINTED OUT THAT THE CAUSE WAS MAINLY DUE TO THE USER TECHNIQUE (SCREW INSERTED IN A FREE HAND MANNER OR BY APPLYING CANTILEVER EFFORT LEADING TO THE RING DISLODGMENT). CONCLUSION: THE REPORTED DEVICE IS AN ANCHOR C DIAM.3.5MM SELF DRILLING 10MM, CATALOG NUMBER 48335310. THE LOT NUMBER OF THE DEVICE IS UNKNOWN. BASED ON ATTACHED PICTURE IT WAS OBSERVED THAT THE LOCKING RING WAS DETACHED FROM THE BONE SCREW. WE RECOMMEND REFERRING TO OUR SURGICAL TECHNIQUE, ON PAGE 13: TO ENSURE PROPER DEPTH AND ADEQUATE LOCKING WHEN USING THE AWL, DRILLING, OR LOCKING BONE SCREWS, USE OF A FREE HAND TECHNIQUE IS STRONGLY DISCOURAGED. USE OF THE GUIDE/INSERTER TIP IS REQUIRED. EXCESSIVE PIVOTING OR ANGULATION ON THE SCREWDRIVER WHILE ATTACHED TO THE SCREW SHOULD BE AVOIDED AS IT CAN CAUSE DAMAGE TO THE SCREWDRIVER AND/OR SCREW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE SURGEON WAS IMPLANTING AN ANCHOR-C SCREW USING THE NEW INSERTER THE LOCKING RING ON THE SCREW CAME APART FROM THE SCREW. THE INITIAL HOLE WAS MADE WITH AN AWL AND A 10MM SELF DRILLING SCREW WAS USED. THE DAMAGED SCREW WAS REPLACED WITH A 4.0 X 12MM SCREW WITHOUT INCIDENT. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHEN THE SURGEON WAS IMPLANTING AN ANCHOR-C SCREW USING THE NEW INSERTER THE LOCKING RING ON THE SCREW CAME APART FROM THE SCREW. THE INITIAL HOLE WAS MADE WITH AN AWL AND A 10MM SELF DRILLING SCREW WAS USED. THE DAMAGED SCREW WAS REPLACED WITH A 4.0 X 12MM SCREW WITHOUT INCIDENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40666 ANCHOR C DIAM.3.5MM SELF DRILLING 10MM IMPLANT OVE STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR