BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER

    MDR report key: 4267590 · Received November 20, 2014

    Report

    Report Number
    3003875359-2014-10386
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: LOT 1547057/5396016: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A SERVICE EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE ITEM WAS NOT WORKING PROPERLY. THE REPAIR TECHNICIAN REPORTED THE ITEM HAD LOOSE AND WORN PARTS. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON (B)(4) 2014. THE EVALUATION WAS CONFIRMED. A PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED. THE SECOND OF THREE TENSIONERS, PART NUMBER 03.311.001 AND LOT NUMBER 5396016, WAS RECEIVED WITH THE SHAFT OF THE DEVICE INTACT. THE BALANCE IS IN GOOD CONDITION WITH ONLY SURFACE SCRATCHES AND THE ETCHINGS ARE LEGIBLE. THREE TENSIONERS, PART NUMBER 03.311.001, WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT WILL NOT FUNCTION: FELL APART.¿ THIS DEVICE IS INTENDED FOR USE IN THE DISTRACTION OSTEOGENESIS (DO) RING SYSTEM FOR THE TREATMENT OF LONG BONE FRACTURES (OPEN AND CLOSED) OF ADULT AND PEDIATRIC PATIENTS THAT REQUIRE EXTERNAL FIXATION. THIS INFORMATION IS PROVIDED PER THE DISTRACTION OSTEOGENESIS RING SYSTEM: FEMUR FRAME TECHNIQUE GUIDE, (B)(4). THE TWO RETURNED TENSIONERS, LOT NUMBER 5241942 (SUPPLIER LOT NUMBER 1486995), WERE MANUFACTURED MAY, 2006 AND THE RETURNED TENSIONER, LOT NUMBER 5396016 (SUPPLIER LOT NUMBER 1547057), WAS MANUFACTURED DECEMBER 2006. THEY WERE ALL RECEIVED WITH LOOSE AND WORN COMPONENTS. ONE TENSIONER FROM LOT NUMBER 5241942 WAS RECEIVED WITH THE BLACK HANDLE REMOVED AND THEREFORE, THE SHAFT COMPONENTS ARE NO LONGER RETAINED ON THE SHAFT. THERE ARE ALSO DENTS ON THE SHAFT OF THE DEVICE. THE SECOND TENSIONER FROM LOT NUMBER 5241942 AND THE TENSIONER FROM LOT NUMBER 5396016 WERE RECEIVED WITH THE HANDLE AND SHAFT INTACT BUT WITH THE DISTAL COMPONENTS LOOSE. THESE DEVICES ALL SHOW SURFACE SCRATCHES AND THE DISTAL REACTION FORK COMPONENTS ON ALL THREE TENSIONERS WERE LOOSE AND COULD BE REMOVED. THESE DEVICES ARE NOT INTENDED TO BE DISASSEMBLED, THUS, THE COMPLAINT CONDITION IS CONFIRMED AND COULD BE REPLICATED AS THE REACTION FORKS ALL EASILY COME APART. THE DEVICES WERE ALL MANUFACTURED PRIOR TO THE RELEASE OF THE CURRENT DRAWING REVISION. THEREFORE, A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWING, THE REVISION AT THE TIME OF MANUFACTURE, AND THE DESIGN HISTORY WERE PERFORMED. THE DRAWING WAS REVISED IN MARCH, 2013 TO INCREASE THE TIGHTENING TORQUE ON THE SPIRALOCK THREAD SPECIFICATION SO THAT THE DEVICE WILL NOT DISASSEMBLE DURING USE. THUS, THE COMPLAINT CONDITION IS LIKELY A RESULT OF THIS DESIGN DEFICIENCY BUT IT HAS ALREADY BEEN ADDRESSED. THE REMAINING DESIGN REVISIONS WERE FOUND TO BE UNRELATED TO THE COMPLAINT CONDITION AND THE CURRENT DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE. IN CONCLUSION, THE COMPLAINT CONDITION IS CONFIRMED. THE COMPLAINT CONDITION IS THE RESULT OF A DESIGN DEFICIENCY BUT IT HAS ALREADY BEEN ADDRESSED. THE CURRENT DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE AND THE RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT CONDITION. THE ORIGINALLY REPORTED SERIAL NUMBER IS ACTUALLY THE SUPPLIER LOT NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTRACTION OSTEOGENESIS TENSIONERS WERE NOT WORKING PROPERLY DURING THE CASE. A TENSIONER CAME APART, WAS PUT BACK TOGETHER AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754683 TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 5396016

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR