BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BLADE W/16

    MDR report key: 3233810 · Received July 18, 2013

    Report

    Report Number
    8030965-2013-04397
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN ANALYSIS WAS CONDUCTED AND IT STATES THAT THE PRESENT CHISEL BLADES WERE EVALUATED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE BLADES ARE BADLY DAMAGED AND DEFORMED. SINCE WE WERE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE, IT MAY BE DUE TO MECHANICAL OVERLOAD.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY, THE CHISEL BLADES RECEIVED OVER THE LAST COUPLE OF MONTHS WERE SOFTER, AND BENDING ALMOST LIKE BUTTER. THIS WAS OBSERVED IN THE OPERATING ROOM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333921 CHISEL BLADE W/16 FZO SYNTHES GMBH T979654

    Patients

    Seq Age Sex Outcome Treatment
    1