BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RACK Ø6.5/7.3

    MDR report key: 3192710 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03541
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 30, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND THE LENGTH SCALE WAS NOT APPLIED ACCORDING TO SPECIFICATIONS. THE INVESTIGATION SHOWED THAT THE LENGTH SCALE WAS NOT APPLIED ACCORDING TO OUR SPECIFICATIONS. THIS IS CLEARLY A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW LENGTH WAS INCORRECT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292026 RACK Ø6.5/7.3 HWC SYNTHES GMBH 3828998

    Patients

    Seq Age Sex Outcome Treatment
    1