BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY CHISEL 5MM

    MDR report key: 3013575 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10548
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 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. PRODUCT DEVELOPMENT EVALUATION REPORTS THE SAMPLE WAS RECEIVED WITH THE IMPACT BUTTON BROKEN OFF THE BACK OF THE CHISEL SHAFT. THE CLEARANCE BETWEEN THE INNER DIAMETER OF THE BUTTON AND THE OUTER DIAMETER OF THE SHAFT COULD BE A LINE TO LINE FIT WHICH COULD MINIMIZE THE ABILITY OF THE BRAZING MATERIAL TO FLOW BETWEEN THE TWO PARTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED VALID FROM A MANUFACTURING PERSPECTIVE FOR THE JOINT BETWEEN THE SHAFT AND THE IMPACT BUTTON. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 2-LEVEL PRODISC-C AT C5-C7 PROCEDURE, THE BACK STOP OF THE CHISEL POPPED OFF WHEN THE SURGEON USED THE SLAP HAMMER. THE BROKEN FRAGMENT WAS RETRIEVED. SURGEON COMPLETED THE PROCEDURE WITH THE CHISEL WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115455 SECONDARY CHISEL 5MM FZX SYNTHES GMBH T924178

    Patients

    Seq Age Sex Outcome Treatment
    1