BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL KEEL CUTTING H7

    MDR report key: 3191463 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03170
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    March 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES INC.
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. SUBJECT DEVICE WAS EVALUATED. NO DEFECT OF THE DEVICE WAS FOUND. THE DEVICE FRACTURED DUE TO EXPERIENCING FORCES GREATER THAN NORMALLY SEEN IN THE INTENDED USE. A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED.

    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.(B)(4): DEVICE HISTORY RECORD REVIEW: MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY PROCEDURE USING THE 7 MM CHISEL A PORTION OF THE CHISEL BLADE BROKE FREE FROM THE HANDLE. THE BROKEN SECTION OF THE BLADE WAS REMOVED AND IT WAS NOT REPORTED THAT THERE WAS ANY EFFECT ON THE PATIENT. IT WAS NOT REPORTED THAT THERE WAS ANY INCREASE IN SURGERY TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291464 CHISEL KEEL CUTTING H7 FZO SYNTHES INC. T928784

    Patients

    Seq Age Sex Outcome Treatment
    1