BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX

    MDR report key: 3021490 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10485
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT OTHER THAN RESIDUAL MARKINGS TYPICAL OF NORMAL USE, THERE IS NO VISIBLE DAMAGE OR DEFORMITY TO EITHER INSTRUMENT. THE DEVICES FUNCTION INDEPENDENTLY AS INTENDED. INITIAL EXAMINATION REVEALED NO FUNCTIONAL OR DESIGN ABNORMALITIES WITH RESPECT TO DRIVER ASSEMBLIES OR SCREW LOADING. TO CONFIRM, THE HOLDING SLEEVES WERE COUPLED WITH A STANDARD T25 DRIVER AND RATCHETING T-HANDLE, AND LOADED WITH ONE PRE-ASSEMBLED POLY-AXIAL MATRIX PEDICLE SCREW; THIS PROCESS WAS COMPLETED WITHOUT INCIDENT. THIS WAS REPEATED SEVERAL TIMES TO ENSURE THAT NO UNANTICIPATED SCENARIOS OCCURRED. THE SCREW WAS THEN DRIVEN ITS ENTIRE LENGTH INTO A 20PCF SAW BONES FOAM BLOCK, AND SUBSEQUENTLY BACKED-OUT AND DISASSEMBLED FROM THE HOLDING SLEEVE WITHOUT EXPERIENCING ANY UNANTICIPATED NEGATIVE BEHAVIORS FROM THE INSTRUMENT. THE MATRIX SURGICAL TECHNIQUE GUIDES, AS WELL AS OTHER PRODUCT SUPPORT INFORMATION, FULLY ILLUSTRATE THE PROPER METHOD OF LOADING AND UNLOADING MATRIX PEDICLE SCREWS USING A LOCKING HOLDING SLEEVE IN CONJUNCTION WITH A MATRIX T25 DRIVER. EVIDENCE WOULD INDICATE THAT THE ISSUE WAS CAUSED BY UNFAMILIARITY WITH INSTRUMENT FUNCTION; PD EVALUATION OF EACH HOLDING SLEEVES FUNCTIONAL CYCLE PROVIDES ADDITIONAL EVIDENCE TO THIS THEORY, WITH RESULTS CONSISTENTLY DISPLAYING ACCEPTABLE PERFORMANCE FROM THE HOLDING SLEEVE ASSEMBLIES. DUE TO THE LACK OF EVIDENCE REGARDING DEFICIENT PERFORMANCE, IT IS CONCLUDED THAT THIS COMPLAINT MUST RENDERED INVALID. THE MANUFACTURING EVALUATION SHOWED THAT A VISUAL INSPECTION OF THE RETURNED PARTS REVEALED VERY SUPERFICIAL SCRATCHES AND WEAR MARKS ON THE 8.35-8.45MM SHAFT. THE PARTS DO NOT HAVE VISIBLE SIGNS OF DAMAGE OR COSMETIC NONCONFORMANCE BUT WHEN THE GREEN LOCKING RING IS PULLED UP THERE ARE TWO DISTINCT WEAR AREAS THAT CAN BE OBSERVED ON THE SIDE OF THE LOCKING RING. THE MULTIPLE SCRATCHES (THROUGH ANODIZE, FOUND ON THE LOCKING RING) ARE NOT CONSISTENT WITH MANUFACTURING OR INSPECTION PROCESSES. THE LOCKING HOLDING SLEEVE PASSED THE FUNCTIONAL CHECKS. QUALITY ENGINEERING EVALUATION PERFORMED FUNCTIONAL TESTING AND FOUND DEVICE TO PERFORM AS DESIGNED MEANING THAT GREEN RING WAS MOVING IN BOTH DIRECTIONS. INSTRUMENT RETURNED CONFORMS TO THE DRAWING SPECIFICATIONS AND FUNCTIONS AS INTENDED. THE RESISTANCE FELT WHEN MOVING THE GREEN LOCKING RING IS A NORMAL AND INTENTIONAL ATTRIBUTE OF THE DEVICE. BASED ON THE EVALUATION PERFORMED AND ON THE FUNCTIONAL TESTS PERFORMED, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN LS RING ON THE HOLDING SLEEVE WOULD NOT POP UP TO LOAD THE SCREW. THIS HAPPENED ON TWO HOLDING SLEEVES. CONSULTANT HAD TWO ADDITIONAL SLEEVES IN THE SET WHICH SURGEON USED TO COMPLETE THE CASE WITHOUT FURTHER PROBLEMS. COMPLAINT HANDLING UNIT REVIEW OF COMPLAINT HISTORY REVEALED THESE ARE THE FIFTH AND SIXTH DEVICES FROM THIS LOT THAT HAVE NOT PERFORMED. PRIOR EVALUATION BY PRODUCT DEVELOPMENT INDICATES DEVICES MAY NOT HAVE BEEN MANUFACTURED CORRECTLY. THE FIRST SUSPECT DEVICE WENT BACK TO SUPPLIER FOR A SECOND EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123433 LOCKING HOLDING SLEEVE- STANDARD FOR MATRIX LXH SYNTHES MONUMENT 6738069

    Patients

    Seq Age Sex Outcome Treatment
    1