BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW BLAD 105° ANGLED 7*11.5*0.4 SHAFT 70

    MDR report key: 3142486 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02614
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE SAW BLADE HAS INDEED SNAPPED OFF NEAR THE WELDED JOINT. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. 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. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND WE HAVE TO ASSUME THAT HIGH APPLIED MECHANICAL FORCES CAUSED THE BREAKAGE. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ASSUME THAT THE COMPLAINT CONDITION IS DUE TO HIGH MECHANICAL FORCES APPLIED TO THE DEVICE WHICH CAUSED THE BREAKAGE AND THEREFORE USER ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE SNAPPED OFF NEAR THE WELDED JOINT. 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
    245043 SAW BLAD 105° ANGLED 7*11.5*0.4 SHAFT 70 GFA SYNTHES GMBH 3555686

    Patients

    Seq Age Sex Outcome Treatment
    1