BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL F/MIDLINE MARKING W/8 L250

    MDR report key: 3171570 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03393
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE RETURNED CHISEL REVEALED THAT THE BLADE BROKE OFF. DUE TO THE MISSING INFORMATION RELATED TO THIS INCIDENT, THE FAILURE CAUSE CAN NOT BE DETERMINED. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. FURTHERMORE, THE INVESTIGATION WITH THE MATERIAL AND MANUFACTURE DOCUMENTS SHOWED THAT THE CHISEL AT HAND WHICH WAS MANUFACTURED IN OCTOBER 2008 ACCORDING TO THE VALID SPECIFICATIONS AND HAS BEEN IN USE SINCE THEN. NO PRODUCT DEFECTS WERE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CHISEL IS BROKEN AND REVEALS INDENTS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272595 CHISEL F/MIDLINE MARKING W/8 L250 HWM SYNTHES GMBH T954139

    Patients

    Seq Age Sex Outcome Treatment
    1