BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC

    MDR report key: 3010016 · Received March 18, 2013

    Report

    Report Number
    2530088-2013-10248
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ALIF PROCEDURE AT L5-S1, THE SHAFT OF THE SCREWDRIVER BROKE DURING SCREW TIGHTENING. THE BROKEN TIP WAS REMOVED FROM THE SCREW HEAD AND DISCARDED. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ALIF - ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AND THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111936 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC HXX SYNTHES BRANDYWINE 4730142

    Patients

    Seq Age Sex Outcome Treatment
    1