BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEM EXTRACTOR F/GUIDE BAR 03.401.070

    MDR report key: 3082130 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11174
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 17, 2011
    Report Date
    November 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER CAREGIVERS

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT . WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SYNTHES SHOULDER/ELBOW PRODUCT SPECIALIST THAT A PATIENT APPROXIMATELY 2 YEARS STATUS POST EPOCA SHOULDER PROSTHESIS IMPLANTATION, WAS RETURNED TO OR ON (B)(6) 2011, DUE TO CONTINUED DEGENERATION OF SHOULDER. THE SURGEON REMOVED THE EPOCA IMPLANT SYSTEM, INCLUDING THE STEM, ECCENTER, GLENOID AND THE HEAD, UTILIZING THE EPOCA REVISION SET 01.401.005. WHILE REMOVING THE STEM, THE SURGEON WAS USING THE STEM EXTRACTOR 03.401.072, AND THE HEX SCREW ON THE EXTRACTOR BROKE AT THE HEAD/ SHAFT JUNCTION. THE SURGEON WAS ABLE TO USE A FEMORAL NAIL EXTRACTOR TO REMOVE THE STEM, AND COMPLETED THE EXPLANT. THE SYNTHES SHOULDER/ELBOW SPECIALIST NOTED THAT THIS WAS AN OFF-LABEL USE OF THE FEMORAL NAIL EXTRACTOR. THE PATIENT WAS THEN REVISED TO A REVERSE SHOULDER ARTHROPLASTY SYSTEM OF A COMPETITOR. EVENT #1 OF 5 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184535 STEM EXTRACTOR F/GUIDE BAR 03.401.070 HWB SYNTHES GMBH 09-6793

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR