BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY CHISEL 5MM

    MDR report key: 3070080 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-11119
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE DEVICE APPEARS TO BE USED AND THE HEAD FOR THE SLAP HAMMER IS BROKEN OFF. THE INSTRUMENT HAS THE CAP BROKEN OFF WHERE THE SLAP HAMMER INTERFACES. BASED ON AN INVESTIGATION CONDUCTED DURING AN INTERNAL CORRECTIVE ACTION TO ADDRESS THIS ISSUE, THE DISASSEMBLY OF THE CHISEL DURING USE CAN BE ATTRIBUTED TO A COMBINATION OF IN SUFFICES IN THE DESIGN AND OR THE MANUFACTURING PROCESS OF THE DEVICE. BASED ON THE INVESTIGATION IT IS CONCLUDED THAT THIS COMPLAINT IS CONSIDERED VALID. THE DEFICIENCIES FOUND IN THE INTERNAL CORRECTIVE ACTION HAVE BEEN ADDRESSED WITH THE RELEASE OF (B)(4). THIS INSTRUMENT WAS MANUFACTURED IN 2008 BEFORE THE DESIGN CHANGES FOUND IN (B)(4). CURRENT INVENTORY HAS BEEN DISPOSITIONED AS USE AS IS BECAUSE THE PATIENT RISK FOR THIS FAILURE IS LOW.

    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. DATE RECEIVED BY MANUFACTURER: ORIGINAL AWARENESS DATE IS 12/14/2011.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT CODE CHANGED TO FZO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS TAMPING IN CHISEL USING A SLAP HAMMER, THE STOP ON THE CHISEL BROKE OFF. THERE WAS NO HARM TO PATIENT. CHISEL IS AVAILABLE FOR RETURN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171587 PRIMARY CHISEL 5MM FZO SYNTHES GMBH T921763

    Patients

    Seq Age Sex Outcome Treatment
    1