BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE F/MF-CORT-SCR Ø2+2.4 F/6-40

    MDR report key: 3193332 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03578
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HTJ
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE EXAMINATION HAS CONFIRMED THAT THE DEPTH GAUGE MEETS SPECIFICATIONS IN TOTAL. THE INSTRUMENT TESTED FOR FUNCTIONALITY, AND WORKED WITHOUT PROBLEMS. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THE DEPTH GAUGE DID NOT PROVIDE ACCURATE READING. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293435 DEPTH GAUGE F/MF-CORT-SCR Ø2+2.4 F/6-40 HTJ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1