BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC

    MDR report key: 3120328 · Received May 20, 2013

    Report

    Report Number
    8030965-2013-02185
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE DRIVER IS MISSING APPROXIMATELY 2.5MM OF THE HEX DRIVE TIP. THE FRACTURED COMPONENT WAS LEFT IN THE PATIENT. THE INTACT PORTION OF THE HEX DRIVE IS TWISTED IN AN ORIENTATION CONSISTENT WITH TIGHTENING THE SCREWS. THE CHU ENGINEER CALCULATED THE FAILURE IN SHEAR CAN OCCUR AT APPROXIMATELY 9.38 N-M. THE TECHNIQUE GUIDE STATES TO USE THE 7 N-M TORQUE LIMITING HANDLE WHILE FINAL TIGHTENING. THERE IS NO INFORMATION AS TO HOW MUCH TORQUE WAS APPLIED DURING FINAL TIGHTENING OR WHETHER OR NOT THE TORQUE LIMITING HANDLE WAS USED. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE DEVICE INTENDED USE. BASED ON THE NUMBER OF ATB SCREWS SOLD BETWEEN APRIL 2011 AND APRIL 2013, THE OCCURRENCE RATE OF THE DRIVER TIP BREAKING AND REMAINING IN THE PATIENT IS APPROXIMATELY (B)(4) PERCENT. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DEVIATION WAS FOUND. AS DOCUMENTED IN THE MANUFACTURING DOCUMENTS THE USED MATERIAL WAS 440A AND THE HARDNESS WAS WITH 52.5HRC AS REQUIRED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. IT IS CLEARLY VISIBLE THAT THE HEXAGON WAS TWISTED BEFORE IT BROKE. THIS INDICATES THAT TOO MUCH TORQUE WAS APPLIED DURING THE INSERTION OF A SCREW. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AND THE TORQUING OF SCREWS, THE END OF THE DRIVER SHEARED OFF AND REMAINED IN THE HEAD OF A SCREW. SCREW AND TIP OF DRIVER REMAIN IN PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222355 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC HXX SYNTHES GMBH 7534430

    Patients

    Seq Age Sex Outcome Treatment
    1