BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX FEMORAL INSERTER

    MDR report key: 1971871 · Received January 17, 2011

    Report

    Report Number
    3006108336-2011-00001
    Event Type
    Other
    Date Received
    January 17, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    K083612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY CAUSE OF THE BALL RETAINER TUBE DISLODGING FROM THE INSERTER IS THE TAB FEATURE ON THE RETURNED BALL RETAINER TUBE ((B)(4)) WAS NOT FULLY DEPLOYED IN THE RECEIVING FEATURE OF THE (B)(4) HEX TUBE. WHEN THE PURPLE KNOB WAS RETRACTED (IN THE FEMORAL TUNNEL), THE IMPLANT DISENGAGED AS DESIGNED, BUT WHEN THE KNOB WAS RELEASED (IN THE TIBIAL TUNNEL), THE BALL DETENT ROD ((B)(4)) PUSHED THE BALL RETAINER TUBE AND FORCED IT FORWARD, PARTIALLY EXITING THE INSERTER BECAUSE OF THE OVER-SIZED TENDONS, THE LASER CUT FEATURES ON THE TUBE CAUGHT THE TISSUE OF THE TENDONS. THE INSERTER WAS REMOVED AS USUAL, BUT THE BALL RETAINER TUBE WAS PULLED FROM THE HEX TUBE ((B)(4)) LEAVING IT IN PLACE WITHIN THE TENDON BUNDLE OF THE TIBIAL TUNNEL. THE INSERTER MAY HAVE BEEN DAMAGED DURING OFF-AXIS INSERTION. THE FAILURE RATE FOR BALL RETAINER TUBE SEPARATION HAS BEEN (B)(4) IN 48 MONTHS PERIOD ((B)(4)). ACCORDING TO INTERNAL PROCEDURE (B)(4), THIS RATE IS CONSIDERED AS IMPROBABLE ((B)(4)). THE LIKELIHOOD OF OCCURRENCE IN THE FUTURE REMAINS THE SAME OR LESS SINCE THE MANUFACTURING PROCESS OR DESIGN HAS NOT BEEN CHANGED AND ADDITIONAL CONTROLS HAVE BEEN ADDED. THERE IS A 100% VISUAL INSPECTION STEP FOR THE ASSEMBLY OF THIS PART. CAYENNE MEDICAL IS ADDING ADDITIONAL CONTROLS FOR THIS ASSEMBLY STEP, (B)(4). THIS COMPLAINT CASE IS CONSIDERED AS AN ISOLATED INCIDENT WHERE THE MANUFACTURING OPERATOR POTENTIALLY DID NOT FOLLOW THE ASSEMBLY INSTRUCTIONS WHEN MAKING THIS UNIT. THIS ASSEMBLY STEP IS MANUAL; THERE IS A 100% VISUAL INSPECTION IN PLACE AT THE VENDOR. NO ADDITIONAL WARNING IS REQUIRED FOR THE FIELD OR USERS.

    Description of Event or Problem · 1

    A (B)(4) BALL RETAINER TUBE FROM AN APERFIX FEMORAL INSERTER WAS RETURNED TO CAYENNE MEDICAL FROM A HOSPITAL IN (B)(6). THIS PARTICULAR PART WAS REMOVED FROM A PATIENT'S KNEE ON (B)(6) 2010, (B)(6) WEEKS AFTER THE ORIGINAL SURGERY, ((B)(6) 2010) WITHOUT INCIDENT. AN X- RAY OF THE KNEE POST-OP ((B)(6) WEEKS AFTER) SHOWS THE BALL RETAINER TUBE INSIDE THE PATIENT'S KNEE. THE BALL RETAINER TUBE IS MADE OF STAINLESS STEEL, TYPE 316L. THE SURGERY ON (B)(6) 2010, WAS A REVISION TO RECONSTRUCT THE RE-TORN ACL WITH THE APERFIX FEMORAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APERFIX FEMORAL INSERTER INSERTER LXH CAYENNE MEDICAL, INC. CM2911 088817210C

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention