BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR

    MDR report key: 2982854 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00675
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRIMARY PURPOSE OF THE U-JOINT MECHANISM ON THIS INSTRUMENT IS TO ALLOW FOR THE TRANSMISSION OF TORQUE TO THE INSTRUMENT'S WORKING END AT DIVERGENT ANGLES THE ACCESS EXPOSURE WOULD OTHERWISE NOT ACCOMMODATE FOR A STRAIGHT INSTRUMENT. AS THESE DEVICES WITH A LOSS OF POSITION RETENTION CAN STILL PERFORM THEIR PRIMARY FUNCTION OF TRANSMITTING TORQUE TO THE DRIVER TIP FOR THE INSERTION OF SCREWS INTO THAT VERTEBRAL BODY, THE DESIGN IS ADEQUATE FOR THE APPLICATION WITH THE USE OF THE GUIDING FORCEPS AS SPECIFIED IN THE TECHNIQUE GUIDE. PER THE TECHNIQUE GUIDE, THE TAPERED U-JOINT DRIVER, (B)(4) IS TO BE USED WITH GUIDING FORCEPS, (B)(4), FOR POSITION GUIDANCE AND DIRECTIONAL CONTROL INTO AND OUT OF THE AIMING DEVICE DURING THE PROCEDURE. MECHANICAL TESTING WAS PERFORMED TO TEST THE SCREW-THROUGH PROPERTIES, (B)(4). (B)(4). ALTHOUGH NO TORQUE LIMIT SPECIFICATION IS INCLUDED IN THE TECHNIQUE GUIDE, INSTRUCTIONS FOR USING TIGHTENING TORQUE USING JUST 4 FINGERS IS MENTIONED. THE TECHNIQUE GUIDE ALSO MENTIONS THE FOLLOWING, AS SOON AS THE RING MARKED ON THE SCREWDRIVER MEETS THE ENTRY POINT OF THE AIMING DEVICE; THE SCREW IS LOCKED TO THE PLATE AND SHOULD NOT BE ADVANCED FURTHER. THE SCREW IS UNDAMAGED AND INTACT; SHOWS MARGINAL WEAR ON THE LOCKING THREAD OF THE HEAD. ALL DIMENSIONS AND TOLERANCES OF THE SCREW ARE WITHIN THE PRESCRIBED SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOT YET COMPLETE.

    Description of Event or Problem · 1

    DURING SURGERY FOR AN ALIF PROCEDURE, THE PLATE CRACKED WHILE TRYING TO INSERT THE 3RD SCREW INTO PLATE. THE THREE DRIVERS LOOSENED WHILE INSERTING AND REMOVING THE SCREWS. THE BROKEN PLATE WAS REMOVED AND A NEW PLATE AND SCREWS WERE IMPLANTED. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87815 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR MAX SYNTHES GMBH 8169816

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention