BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY STENT ACCESS KIT

    MDR report key: 3193251 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03976
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    July 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KIH
    PMA / PMN Number
    EXEMPT
    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. ADDITIONAL PRODUCT CODES: FZX, HXG, HTW, MJG. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE WORKING SLEEVE WAS COMPLETELY BROKEN OFF AT TWO PLACES. THE WORKING SLEEVE IS ALSO RIPPED AT ONE PLACE AND THE PART IS COMPLETELY FLATTENED. THE PLASTIC T-HANDLE IS RIPPED FROM THE SIDE TO THE MIDDLE. THE REVIEW OF THE MATERIAL AND PRODUCTION DOCUMENTS HAS SHOWN NO SIGNS OF DEVIATIONS FROM SYNTHES SPECIFICATIONS. UNFORTUNATELY, THE EXACT CAUSE CAN NO LONGER BE DETERMINED. BASED ON THE DHR REVIEW, THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE T-HANDLE SLID OFF OF THE WORKING SHAFT. THE WORKING SHAFT STAYED IN THE PEDICLE AND WAS VERY DIFFICULT TO REMOVE FROM THE PEDICLE. THE REMOVAL OF THE WORKING SHAFT WITHOUT THE T-HANDLE WAS ONLY POSSIBLE BY MEANS OF FLAT NOSE PLIERS AND/OR HAEGER NEEDLE HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292503 VERTEBRAL BODY STENT ACCESS KIT KIH SYNTHES GMBH AJR718

    Patients

    Seq Age Sex Outcome Treatment
    1