BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE DEPTH LIMITER F/SCR Ø5/6/7

    MDR report key: 3183598 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03349
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    August 27, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    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. THE ADDITIONAL EVALUATION REVEALED THAT THE SHEATH IS BROKEN. DUE TO THE DAMAGE PATTERN DISCERNIBLE THE CAUSE CANNOT BE CLEARLY DETERMINED. WE CAN ONLY ASSUME THAT EXCESSIVE MECHANIC STRESS CAUSED THE SHEATHS TO BREAK. ALSO, THE PRECISE LOT NUMBERS OF THESE SHEATHS IS UNKNOWN IT IS IMPOSSIBLE TO DEFINE THE PRODUCTION PERIOD AND TO VERIFY THE RESPECTIVE PRODUCTION DOCUMENTS. THUS IT CAN ONLY BE CONFIRMED THAT OUR ADJUSTABLE DEPTH-LIMITING ¿ SHEATHS COMPLY WITH THE AO-ASIF SPECIFICATIONS AND THE INTERNATIONAL STANDARDS. BASED ON THIS RESULT, WE CAN EXCLUDE A PRODUCTION ERROR. NO PRODUCT FLAW COULD BE DETERMINED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATH BROKE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284411 ADJUSTABLE DEPTH LIMITER F/SCR Ø5/6/7 HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1