BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2945322 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10024
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    March 22, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SAMPLES WERE RECEIVED WITH ONE BROKEN TIP AND TWO TWISTED TIPS. VISUAL INSPECTION NOTED A HOMOGENOUS FRACTURE FACE POSSIBLY INDICATING MATERIAL CONFORMITY AND A FORCED RUPTURE. THE LOT NUMBER PROVIDED IS INVALID THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. THERE WERE NO FAULTS DETECTED IN THE MANUFACTURING REVIEW THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSULTANT THAT DURING A SPINE PROCEDURE THE HEXAGONAL SCREWDRIVER WITH T-HANDLE WAS USED TO INSERT A VARIABLE AXIS SCREW AND THE TIP BROKE OFF INSIDE THE HEAD OF THE SCREW. THE SURGEON REMOVED THE SCREW AND THE BROKEN SCREWDRIVER TIP AND REPLACED THE SCREW WITH THE NEW ONE. TWO ADDITIONAL HEXAGONAL SCREWDRIVERS WITH T-HANDLE WERE USED TO COMPLETE THE PROCEDURE. THIS COMPLAINT IS ON THE 1ST SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45227 3.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 1985567

    Patients

    Seq Age Sex Outcome Treatment
    1 HEXAGONAL SCREWDRIVER WITH T-HANDLE SCREW