BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME-EXTENSION W/JOINT

    MDR report key: 3171595 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02788
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    May 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION REPORT OF THE PROVIDED INSTRUMENT SHOWS THAT THE LOCKING BOLT BROKE OFF. THE EXACT CAUSE FOR THIS REPORTED PROBLEM IS UNDETERMINED. THE BREAKAGE IS INDICATIVE OF THE RETAINER BOLT BEING TWISTED BEYOND ITS ANCHOR WHICH LED TO BEING BROKEN WHEN AN ATTEMPT WAS MADE TO RESCREW, OR THE LOCKING SCREW BROKE BECAUSE IT WAS OVERTIGHTENED. A DOCUMENTATION REVIEW CONFIRMED COMPLIANCE WITH SPECIFICATIONS. PRODUCT DEFECT WAS NOT FOUND. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE LOCKING SCREW BROKE APART INSIDE THE HINGE DURING THE TIGHTENING PROCEDURE. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272424 SYNFRAME-EXTENSION W/JOINT LXH SYNTHES GMBH 3366091

    Patients

    Seq Age Sex Outcome Treatment
    1