BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL F/FOOT STRAIG NARR W/10 L124

    MDR report key: 3141227 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02606
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    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. 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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE DEVICE WAS RETURNED FOR EVALUATION AND VISUAL INSPECTION SHOWED THAT THE PRODUCT CORRESPONDED TO SPECIFICATIONS. THE LASER MARKING WAS OUT OF ORDER AND RUST WAS ON THE INSTRUMENT. THE LASER INSCRIPTION WEARS VERY QUICKLY. FLASH RUST FORMS IN THESE AREAS AS LASER INSCRIPTION DAMAGES THE INSTRUMENTS PASSIVE COATING. THE ROOT CAUSE WAS DETERMINED TO BE IMPROPER PRODUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASER MARKING DISAPPEARS VERY QUICKLY AND RUST ARISES AT THESE POINTS, BECAUSE THE PASSIVE LAYER OF THE INSTRUMENT WAS DAMAGED THROUGH LASER EXPOSURE AT THIS POSITION. THIS IS REPORT 1 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243999 CHISEL F/FOOT STRAIG NARR W/10 L124 FZO SYNTHES GMBH 1074104

    Patients

    Seq Age Sex Outcome Treatment
    1