BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BC DISTRACTOR BODY END ACT. W/U-JOINT 30MM FOR CMF DSTR

    MDR report key: 2933380 · Received January 29, 2013

    Report

    Report Number
    2530088-2013-00099
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    December 7, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE FOOTPLATES APPEARS TO BE CUT AND CONTOURED AS DESCRIBED IN STEP 4 OF THE CMF DISTRACTION SYSTEM TECHNIQUE GUIDE; NO SEVER CONTOURS OR CUTS WERE APPARENT. THE FOOTPLATES AND THE DISTRACTOR BODY APPEARED TO BE ASSEMBLED AS DESCRIBED IN STEP 3B OF THE CMF DISTRACTION SYSTEM TECHNIQUE GUIDE; WITH THE C-TYPE FOOTPLATE ATTACHED AT THE END OF THE DISTRACTOR BODY AND THE B-TYPE FOOTPLATE ASSEMBLED ALONG THE LEAD SCREW OF THE DISTRACTOR BODY. WITH PRESSURE APPLIED, THE B-TYPE FOOTPLATE WAS ACTUATED BY HAND ALONG THE FULL RANGE OF MOTION OF THE DISTRACTOR BODY WITHOUT ANY UNEXPECTED FRICTION, JAMMING OR SLIPPAGE OF THE DEVICE; THIS CONDITION DOES NOT AGREE WITH COMPLAINT CONDITION DESCRIBED. THE BONE WAS HEALED AT THE TIME OF THE REVISION ON (B)(6) 2013 REQUIRING ANOTHER OSTEOTOMY TO BE PREFORMED AS NOTED IN THE ATTACHED PATIENT X-RAYS. GIVEN THE REQUIRED ADJUSTMENTS TO THE DISTRACTION RATE DURING THE PROCEDURE, IT IS POSSIBLE THAT THE BONE PREMATURELY CONSOLIDATED WHICH PREVENTED THE DISTRACTOR ASSEMBLY FROM ADVANCING AS NOTED IN THE COMPLAINT. IT IS ALSO UNKNOWN GIVEN THE ADJUSTMENTS MADE DURING THE PROCEDURE AND THE HEMIFACIAL MICROSOMIA OF THE PATIENT, THE CONDITION AND QUALITY OF BONE WHEN DISTRACTION WAS RESTARTED. THE MECHANISM OF THE NOTED FAILURE CANNOT BE DETERMINED OR DUPLICATED. THE RISK ASSESSMENT FOR THIS DEVICE DOES ADEQUATELY ADDRESS THE COMPLAINT WITH A SEVERITY OF 4, MAJOR, BUT DOES NOT ADEQUATELY ADDRESS THE RATE OF OCCURRENCE DISPOSITIONED AS A 2, UNLIKELY; THE RISK ASSESSMENT WILL BE REVISED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE 04.315.066, BC DISTRACTOR BODY END ACTUATOR W/U-JOINT 30MM FOR CMF DISTRACTOR, LOT NUMBER 6961024, WAS RETURNED WITH WEAR MARKS AROUND THE 30MM ETCHED END. THE DISTRACTOR LASER MARKING IS LEGIBLE. THE BC DISTRACTOR IS ATTACHED TO TWO 04.315.302 FOOTPLATES, LOT NUMBERS 6873098 AND 6940254. THE FOOTPLATES ARE BENT AND SHOW TOOL MARKS AND WORN ANODIZE INDICATIVE OF USE. THE DISTRACTOR DISTRACTS FREELY. THE DISTRACTOR WAS CONFORMING FOR THE FUNCTION TEST. THE DISTRACTOR DISTRACTED WITH NO BINDING. THE COMPLAINT DETAILS DO NOT INDICATE AN ISSUE WITH THE DISTRACTOR AND THE DISTRACTOR WAS FOUND TO FUNCTION APPROPRIATELY AS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH INTERNAL MANDIBLE CMF DISTRACTION ON (B)(6) 2012 FOR HEMIFACIAL MICROSOMIA. PATIENT WAS RETURNED TO THE SURGEON APPROXIMATELY 2 WEEKS POST-OP FOR A FOLLOW-UP VISIT. EXAM AT THAT TIME SHOWED THAT PATIENT WAS BEING OVER-DISTRACTED. REPORTEDLY, THE PARENT OF THE PATIENT MISUNDERSTOOD GIVEN INSTRUCTION, AND WAS TURNING THE DISTRACTOR 3 TURNS, 3 TIMES PER DAY, INSTEAD OF THE RECOMMENDED 1 TURN 3 TIMES PER DAY. THE SURGEON BACKED OUT THE DISTRACTION DEVICE TO ALLOW CALCIFICATION TO BEGIN PROPERLY AT THE PRESCRIBED PACE. SURGEON REINSTRUCTED THE PARENT ON USAGE. PARENT THEN ADVISED SURGEON ON A LATER UNKNOWN DATE, THAT THE DISTRACTOR WAS NOT WORKING AND WAS NOT DISTRACTING AT ALL. ON AN UNKNOWN DATE, THE PATIENT WAS RETURNED FOR REMOVAL OF THE FLEXIBLE EXTENDER. ALSO ON UNKNOWN DATE, SURGEON CALLED PRODUCT DEVELOPMENT TO DISCUSS THE PROBLEM WITH THE DISTRACTOR. IT WAS DECIDED TO GIVE THE PATIENT MORE TIME TO HEAL, AND THEN REVISE THE PATIENT TO ANOTHER DISTRACTOR. ON (B)(6) 2013, SURGEON REMOVED THE ORIGINAL DISTRACTOR AND SIX UNKNOWN SCREWS AND PLACED A NEW DISTRACTION DEVICE. FOLLOWING THE CASE, THE SURGEON AND THE CONSULTANT COULD NOT DUPLICATE THE FAILURE OF THE DISTRACTOR THAT THE PARENT REPORTED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39447 BC DISTRACTOR BODY END ACT. W/U-JOINT 30MM FOR CMF DSTR BC DISTRACTOR BODY END ACT MQN SYNTHES BRANDYWINE 6961024

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention REMOVABLE EXTENSION ARM