BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL-FLAT-STRAIGHT W/8

    MDR report key: 3191528 · Received June 26, 2013

    Report

    Report Number
    8030965-2012-03218
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. PLACEHOLDER.

    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. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THE DEVICE WAS MANUFACTURED IN CONFORMANCE WITH SYNTHES SPECIFICATIONS. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. VISUAL INSPECTION SHOWED EVIDENCE THAT THE CHISEL MAY HAVE HAD CONTACT WITH A METALLIC OBJECT AND WAS BLUNTED INDICATING A MECHANICAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHISEL INSTRUMENT BROKE DURING USE IN SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE DEVICE BROKE DURING SURGERY AFTER ONE YEAR OF USE. THE CUSTOMER COMPLAINED THAT THE PRODUCT WAS NOT DURABLE. THIS IS THE THIRD CHISEL PURCHASED THAT BROKE DURING SURGERY. THE CUSTOMER IS UPSET WITH THE QUALITY OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290083 CHISEL-FLAT-STRAIGHT W/8 FZO SYNTHES GMBH 2639878

    Patients

    Seq Age Sex Outcome Treatment
    1