BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø13.5

    MDR report key: 3142265 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02624
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    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 VISUAL INVESTIGATION CONCLUDED THE COMPLAINT WAS INVALID DUE TO IMPROPER CLEANING AND MAINTENANCE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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 MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    RUST FOUND ON SURFACE OF THE REAMER HEAD INSTRUMENT. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243348 SYNREAM REAMER HEAD Ø13.5 HTO SYNTHES GMBH 21373

    Patients

    Seq Age Sex Outcome Treatment
    1