BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY CHISEL 6MM

    MDR report key: 3041791 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10708
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE DEVICE WAS USED WITH NO OBVIOUS SIGNS OF ABUSE OR MISUSE. THE CAP THAT INTERFACES WITH THE SLAP HAMMER WAS BROKEN OFF. THE INSTRUMENT HAS THE CAP BROKEN OFF WHERE THE SLAP HAMMER INTERFACES. THE DISASSEMBLY OF THE CHISEL DURING USE CAN BE ATTRIBUTED TO A COMBINATION OF INSUFFICIENCIES OF THE DEVICE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THIS INSTRUMENT WAS MANUFACTURED BEFORE THE DESIGN CHANGES WERE IMPLEMENTED.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KNOB ON THE BACK OF THE CHISEL BROKE OFF AT THE LASER WELD DURING A C4-6 CERVICAL ARTHROPLASTY. THE BROKEN PIECE WAS RETRIEVED AND VICE GRIPS WERE USED TO REMOVE THE CHISEL. THERE WAS NO INCIDENT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143716 SECONDARY CHISEL 6MM FZO SYNTHES GMBH T921119

    Patients

    Seq Age Sex Outcome Treatment
    1