BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-LARGE

    MDR report key: 3071834 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-11040
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    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 INSERTER IS MISSING PORTIONS OF THE INFERIOR PINS ON THE TIPS OF THE ARMS THAT ARE INTENDED TO MATE WITH THE INFERIOR PD-L ENDPLATE. THE LEFT PIN IS FRACTURED DISTAL TO THE LOCKING LIP OF THE PIN, WITH THE LIP STILL INTACT. THE RIGHT PIN IS FRACTURED PROXIMAL TO THE LOCKING LIP OF THE PIN, WITH THE LOCKING PIN MISSING. THE FRACTURED TIP PIECES WERE NOT RETURNED. THE REMAINDER OF THE INSTRUMENT HAS MARKS INDICATING USE, WITH DENTS ON THE PROXIMAL SURFACE OF THE CONNECTION BLOCK. 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. TO HELP WITH SITUATIONS WHERE INSERTERS WITH PREVIOUSLY BENT PINS ARE USED, PD HAS ALSO RELEASED NON-STERILE DEMO PARTS (NA0048, NA0049, NA0056, NA0058) WHICH CAN BE USED TO CHECK THE FUNCTIONALITY OF THE INSERTERS BEFORE THE SURGICAL CASE. A SECOND INSERTER IS ALSO PROVIDED IN EACH SET AND CAN BE USED IF ONE OF THE INSERTERS BECOMES UNUSABLE FOR ANY REASON. THE CURRENT (B)(4) FOR THIS INSTRUMENT TYPE (REV A, S04-023) INCLUDES THE BREAKING OF THE INSERTER PINS. WITH SEVERITY 3 AND OCCURRENCE 3, THE POTENTIAL HARMS ARISE FROM AN INCREASE IN OR TIME BECAUSE PINS HAVE TO BE REMOVED FROM THE IMPLANT, OR FROM THE IMPLANT REQUIRING REMOVAL. BASED ON THE CURRENT CLINICAL HISTORY WITH THIS DEVICE, THE SEVERITY AND OCCURRENCE NUMBERS FOR THIS FAILURE MODE REMAIN APPROPRIATE. THE BROKEN INSERTER PINS ARE MOST LIKELY DUE TO EXCESSIVE BENDING MOMENTS BEING APPLIED TO THE INSTRUMENT; HOWEVER THE ROOT CAUSE CANNOT BE DETERMINED FROM THE DESCRIPTION PROVIDED. 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 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 CHANGE OF FRACTURE. THE MANUFACTURING EVALUATION SHOWED THE TWO TIPS OF THE LEFT AND RIGHT ARMS WERE BROKEN OFF. THE INSERTER CORRESPONDS TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. IT IS CONCLUDE THAT TOO MUCH FORCE WAS APPLIED TO THE TIPS CAUSING ONE TO BREAK. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRODISCL ANTROPLASTY PROCEDURE, WHILE INSERTING THE INFERIOR END PLATE, THE INSERTER BROKE. BROKEN PIECES WERE RETRIEVED, AND THERE WAS NO HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172074 INSERTER-LARGE LXH SYNTHES GMBH A7OA23

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR