BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-MEDIUM

    MDR report key: 3050767 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10828
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 7, 2011
    Report Date
    November 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THE RETURNED PDL IMPLANT ENDPLATES WERE TRIED WITH NEW INSERTERS, AND THERE WAS NO DIFFICULTY IN LOADING OR LOCKING THE IMPLANT. THE ENDPLATES WERE FOUND TO BE FUNCTIONING PROPERLY AND DO NOT SUGGEST TO BE THE CAUSE OF THE BROKEN PINS. THE INSERTER DEVICE DESIGN WAS REVIEWED AND FOUND TO BE APPROPRIATE FOR THE INTENDED USE. THE PINS WERE DESIGNED TO ABSORB AN IMPACTION LOAD OF INSERTING THE DEVICE INTO THE DISC SPACE, AND NOT LARGE BENDING MOMENTS. EXCESSIVE BENDING MOMENTS APPLIED TO THE INSTRUMENT FROM NOT FOLLOWING THE RECOMMENDED TECHNIQUE MAY CAUSE THE PINS ON THE INFERIOR ARMS TO BEND AND EVENTUALLY BREAK. IF THE ACCESS ANGLE TO THE SPINE DOES NOT ALLOW DIRECT VISUALIZATION OF THE DISC SPACE AS DIRECTED IN THE TECHNIQUE GUIDE, BENDING MOMENTS MAY BE APPLIED TO THE INSTRUMENT TO CONTINUE WORKING THROUGH THE MISALIGNED EXPOSURE. IN ADDITION, IF THE POSTERIOR RELEASE IS NOT ADEQUATE, THE PINS CAN BEND OR BREAK DURING DISTRACTION. THE BROKEN INSERTER PINS ARE MOST LIKELY DUE TO EXCESSIVE BENDING MOMENTS BEING APPLIED TO THE INSTRUMENT, WITH THE HARSH ACCESS ANGLE REQUIRED TO OPERATE ON L5/S1 ALSO ACTING AS A CONTRIBUTING FACTOR. A SECOND INSERTER OF EACH SIZE IS INCLUDED IN THE INSTRUMENT SET SO THAT A PROCEDURE MAY BE COMPLETED IN THE EVENT THAT ANY CONDITION PREVENTS THE USE OF THIS INSTRUMENT. THE USE OF THE NON-STERILE DEMO PARTS IS HIGHLY SUGGESTED TO CHECK FOR BENT PINS PRIOR TO SURGICAL USE, AS USING BENT PINS WITH ALREADY YIELDED MATERIAL MAY INCREASE THE CHANCE OF FRACTURE. BASED ON THE CONDITION OF THE RETURNED DEVICE AND EVALUATION, THE COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    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 THAT DURING A PRODISC LUMBAR L5-S1 IMPLANT PROCEDURE, AS THE SURGEON WAS INSERTING THE INFERIOR END PLATE THE INSERTER TIPS BROKE OFF IN THE INFERIOR END PLATE. SURGEON REMOVED THE SUPERIOR AND INFERIOR PLATES AND CONTINUED THE PROCEDURE WITH A NEW PRODISC IMPLANT AND ANOTHER INSERTER. ADDITIONALLY, IT WAS NOTED THAT A WHITE PIECE BROKE OFF THE MALLET DURING USE IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153002 INSERTER-MEDIUM LXH SYNTHES GMBH A70A46

    Patients

    Seq Age Sex Outcome Treatment
    1