BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMF SCREW Ø2 L8 SST

    MDR report key: 3161844 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03303
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    July 13, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    K010527
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MEASURABLE DIMENSIONS OF THE SCREW SENT IN WERE CHECKED TO THE EXTENT THEY COULD BE. IT WAS DETERMINED THAT THESE CORRESPONDED TO THE DRAWINGS AND SPECIFICATIONS. BECAUSE THE EXACT LOT NUMBERS OF THIS IMF SCREW IS NOT KNOWN, IT IS NOT POSSIBLE TO DEFINE THE PRODUCTION TIMEFRAME AND VERIFY THE CORRESPONDING PRODUCTION DOCUMENTS. THEREFORE, IT CAN ONLY BE CONFIRMED THAT THE SCREW CORRESPONDS TO SPECIFICATIONS AND THE INTERNATIONAL STANDARDS. NO PRODUCT ERROR COULD BE DETERMINED. THE VISUAL BREAKAGE AREA IS HOMOGENOUS, WHICH INDICATES PERFECT MATERIAL QUALITY. WE UNFORTUNATELY CAN NO LONGER RECONSTRUCT THE EXACT REASON FOR THE PROBLEM THAT AROSE IN HINDSIGHT WITHOUT ADDITIONAL INFORMATION. DUE TO THIS FINDING, WE ASSUME THAT A SHORT-TERM MECHANICAL OVERLOAD LED TO THE BREAKAGE OF THE SCREW. THE COMPLAINT IS DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    SCREWS BROKE OFF. THE SCREW FRAGMENTS COULD BE REMOVED INTRAOPERATIVE. THERE WERE NO OTHER COMPLICATIONS. THE OPERATION WAS ABLE TO BE FINISHED AS PLANNED. THIS IS 1 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262980 IMF SCREW Ø2 L8 SST DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1