BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMF SCREW Ø2 L8 SST

    MDR report key: 3173897 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03335
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    December 20, 2011
    Report Date
    January 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE SCREW IS BROKEN. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES, WHICH INDICATE MATERIAL CONFORMITY AS WELL. WE ASSUME THAT TOO HIGH MECHANICAL FORCE DURING REMOVAL HAS BEEN APPLIED AND CAUSED THE BREAKAGE OF THE SCREW SHAFT. PLEASE NOTE THAT WE HAVE NOT HAD A SINGLE COMPLAINT WITH THIS SCREW SO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW HEAD SNAPPED OFF DURING REMOVAL. ALL BROKEN PARTS HAVE BEEN REMOVED AND WILL BE RETURNED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273625 IMF SCREW Ø2 L8 SST DZL SYNTHES GMBH 7626271

    Patients

    Seq Age Sex Outcome Treatment
    1