BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIRAIL LENGTHENER

    MDR report key: 2057148 · Received March 4, 2011

    Report

    Report Number
    9680825-2011-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE, RECEIVED ON (B)(4) 2011 WAS EXAMINED BY ORTHOFIX QUALITY ENGINEERING DEPARTMENT. THE PRODUCT WAS SUBJECT TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK. THE TECHNICAL ANALYSIS DID NOT EVIDENCE ANY ANOMALIES APART FROM THE CONTAMINATION PRESENT ON THE PRODUCT. THE PRODUCT IS CONFORMING TO ORTHOFIX SPECIFICATION. A STATIC TEST ON THE PRODUCT WILL BE DONE AS SOON AS IT WILL BE AVAILABLE AFTER DECONTAMINATION. AS THE SURGEON HAD DIFFICULTY TO GET THE FIXATOR TO WORK DURING SURGERY, ORTHOFIX CAN PRESUME THAT THIS FIXATOR WAS NOT PROPERLY DECONTAMINATED BEFORE THIS LAST USE. ORTHOFIX INSTRUCTIONS FOR USE (REF. TO LEAFLET PQ EXF) RECOMMENDS THAT "ALL EQUIPMENT SHOULD BE CAREFULLY EXAMINED PRIOR TO USE TO ASSURE PROPER WORKING CONDITION. IF A COMPONENT OR INSTRUMENT IS BELIEVED TO BE FAULTY, DAMAGED OR SUSPECT, IT SHOULD NOT BE USED." MOREOVER, ORTHOFIX LEAFLET PQ ISP CAREFULLY INSTRUCT ON THE CLEANING AND REPROCESSING ACTIVITIES TO BE PERFORMED ON ORTHOFIX REUSABLE DEVICES. THE CLINICAL EVALUATION, MADE BY ORTHOFIX MEDICAL EVALUATOR, EVIDENCED AS FOLLOWS: A FIXATOR M102 IS BEING USED ON THE FOOT OF A YOUNG PATIENT WEIGHING (B)(6). THIS WILL PUT AN ENORMOUS LOAD ON THE FIXATOR. THE ORTHOFIX EXTERNAL FIXATION SYSTEM COMPONENTS ARE NOT INTENDED TO REPLACE NORMAL HEALTHY BONE OR WITHSTAND THE STRESSES OF FULL WEIGHTBEARING, PARTICULARLY IN UNSTABLE FRACTURES OR IN THE PRESENCE OF NON UNION, DELAYED UNION OR INCOMPLETE HEALING (SEE ORTHOFIX INSTRUCTIONS FOR USE, PQ EXF). THE PATIENT MAY HAVE SUFFERED SOME TRANSIENT INSTABILITY, BUT WILL HAVE BEEN CORRECTED PAINLESSLY. THERE WAS NO ADVERSE EFFECT IN THIS PATIENT. AS NO INFORMATION HAVE BEEN PROVIDED BY THE HOSPITAL ON THE SPECIFIC APPLICATION NOR THE X-RAYS HAVE BEEN MADE AVAILABLE, IT IS NOT POSSIBLE TO FINALIZE THE ROOT CAUSE ANALYSIS. (B)(4). ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET. IN CASE ADDITIONAL INFORMATION WILL BECOME AVAILABLE, ORTHOFIX WILL PROMPTLY FINALIZE THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR A MEDIAL COLUMN FUSION IN THE FOOT. THE SURGEON HAD DIFFICULTY DURING SURGERY BUT WAS ABLE TO GET THE FIXATOR TO WORK. WITHIN ONE WEEK OF THE FIXATOR MALFUNCTIONED (CROSS-THREADED) AND WAS REPLACED WITH ANOTHER M102 IN THE PATIENT'S HOME THE SAME DAY. THE PINS WERE LEFT IN AND THE RAIL WAS REPLACED. THE PATIENT DID EXPERIENCE SOME PAIN DURING THIS PROCEDURE. CURRENTLY PATIENT HAS NOT YET FULLY HEALED BUT IS DOING WELL. THE X-RAYS OF THE CASE ARE NOT MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIRAIL LENGTHENER MINIRAIL LONG LENGTHENER JDW ORTHOFIX SRL M102 B26

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR