BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLINEAR REDUCTION CLAMP SLIDING MECHAN

    MDR report key: 3190878 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03960
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    March 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE HANDLE OF THE COLLINEAR REDUCTION CLAMP WAS BROKEN WHEN RECEIVED FOR EVALUATION. THE HANDLE BROKE OFF DUE TO WEAR AND TEAR OR FORCIBLE USE. THE TOOTHED TIP WAS BENT AND BROKEN OFF PIKES CAUSED BY WEAR AND TEAR. THE DEVICE MET FULLY TO OUR SPECIFICATION AT THE TIME OF MANUFACTURING IN APRIL 2005. NO PRODUCT RELATED FAULT WAS FOUND.

    Additional Manufacturer Narrative · 1

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    THE HANDLE OF THE COLLINEAR REDUCTION CLAMP BROKE. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291291 COLLINEAR REDUCTION CLAMP SLIDING MECHAN HTD SYNTHES GMBH 2111565

    Patients

    Seq Age Sex Outcome Treatment
    1