BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER FOR SYNFRAME BONE LEVERS

    MDR report key: 3051860 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10845
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 4, 2011
    Report Date
    October 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE DESIGN DOCUMENTATION FOR THIS INSTRUMENT HAS BEEN REVIEWED AND THERE ARE NO DESIGN ISSUES ASSOCIATED WITH THIS PART. THE DESIGN OF THE PART IS APPROPRIATE FOR ITS INTENDED USE. THE ABILITY OF THE PART TO WITHSTAND RETRACTION FORCES DEPENDS ON A NUMBER OF FACTORS THAT VARY FROM SURGERY TO SURGERY, INCLUDING BUT NOT LIMITED TO PATIENT SIZE AND WEIGHT, INCISION SIZE, AND SURGICAL TECHNIQUE. THEREFORE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS PERFORMING A TOTAL DISC ARTHROPLASTY, USING SYNFRAME STANDARD ACCESS AND PRODISC-L, THE FOLLOWING EVENTS TOOK PLACE: USING THE HOMAN RETRACTOR BLADES, THE SURGEON ATTEMPTED TO PULL THE SUPERIOR GUIDES BACK TO ATTACH TO THE SYNFRAME CLAMP AND THE GUIDE ARM BROKE. THE SURGEON THEN ATTEMPTED THE SAME TASK WITH A SECOND HOMAN RETRACTOR, AND THE SECOND GUIDE ARM BROKE. THE SURGEON USED BACK UP STERILE GUIDE ARM TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148325 HOLDER FOR SYNFRAME BONE LEVERS LXH SYNTHES GMBH 1260190

    Patients

    Seq Age Sex Outcome Treatment
    1