BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03143

    MDR report key: 3171616 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03143
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    March 30, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 MICROSCOPIC VIEW OF THE BROKEN SURFACE IS HOMOGENOUS AND DOES NOT SHOW ANOMALIES. THE MATERIAL IS IN COMPLIANCE WITH SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. DUE TO THE MISSING THREADED PARTS, VERIFICATION OF MEASURABLE DIMENSIONS OF THE BROKEN LOCKING SCREW COULD NOT BE COMPLETED. THE HEAD WAS FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND SPECIFICATIONS. THE EXACT CAUSE OF THIS OCCURRENCE IS UNDETERMINED. THE EXAMINATION OF THE RAW MATERIAL CERTIFICATES AND THE MANUFACTURING PAPERS COULD NOT BE COMPLETED SINCE THE LOT NO. IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE SCREW HEAD BROKE OFF. THIS IS 1 OF 1 REPORT FOR THE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272458 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1