BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TISSUE RETRACT LRG EXTENDIBLE

    MDR report key: 3173042 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03207
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION HAS SHOWN THAT THE CONNECTING NUT IS BROKEN OFF AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND PASSED THE DIMENSIONAL INSPECTIONS. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CONNECTING SCREW BROKE DURING SURGERY ON AN UNKNOWN DATE. THE PLATE WAS SUCCESSFULLY PLACED WITH NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273814 SOFT TISSUE RETRACT LRG EXTENDIBLE GAD SYNTHES GMBH 3366217

    Patients

    Seq Age Sex Outcome Treatment
    1