BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME-EXTENSION W/JOINT

    MDR report key: 3190488 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-04110
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    August 28, 2012
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE INSPECTION OF THE DISPUTED SYNFRAME-EXTENSION SHOWED THAT THE FIXING SCREW OF THE JOINT BROKE. UNFORTUNATELY, A DETERMINATION COULD NOT BE MADE FOR THE EXACT REASON FOR THE PROBLEM. IT IS SUGGESTED, THE FIXING SCREW WAS SCREWED BEYOND ITS SETTING AND BROKE WHEN TRYING TO SCREW IN THE SCREW AGAIN OR THE FIXING SCREW BROKE, BECAUSE IT WAS TOO TIGHT. A FURTHER EXAMINATION OF THE PRODUCTION AND MATERIAL DOCUMENTS SHOWS CONFORMITY TO THE SPECIFICATIONS. FURTHER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED AND IT STATES THE FOLLOWING: THE INVESTIGATION ON THE BASIS OF THE MATERIAL AND PRODUCTION DOCUMENTS HAD SHOWN THAT THE SCREW DRIVER CONFORMS TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED: THE INNER SET SCREW BROKE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291217 SYNFRAME-EXTENSION W/JOINT LXH SYNTHES GMBH 3111805

    Patients

    Seq Age Sex Outcome Treatment
    1