BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTR F/TEMP-REDUCTION F/LCP 4.5/5

    MDR report key: 3193419 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01731
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE MEASURABLE DIMENSIONS OF THE BROKEN TENSION DEVICE WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE VISUAL INSPECTION REVEALED THE CROSS SECTION OF THE BROKEN SURFACE SHOWS NO IRREGULARITIES. THEREFORE IT IS POSSIBLE THAT TOO MUCH MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN HAS BEEN APPLIED DURING SURGERY, WHICH RESULTED IN THE BREAKAGE OF THE DEVICE. NO PRODUCT FAULT COULD BE DETECTED. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6). DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE.

    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.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE DURING THE SURGERY. THE VETERINARY SURGEON STATED THE INSTRUMENT WAS USED ACCORDING TO SPECIFICATION AND NO EXCESS FORCE WAS APPLIED TO THE INSTRUMENT DURING THE PROCEDURE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291938 INSTR F/TEMP-REDUCTION F/LCP 4.5/5 HTD SYNTHES MONUMENT PE00068

    Patients

    Seq Age Sex Outcome Treatment
    1