BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAFIX TIBIAL SHEATH INSERTER

    MDR report key: 2133762 · Received June 20, 2011

    Report

    Report Number
    1221934-2011-00243
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND WAS VISUALLY EXAMINED. THE DISTAL TIP OF THE TRIAL IS MISSING; HAS BROKEN AWAY AT THE WELD. NO LOT NUMBER WAS ABLE TO BE SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUTSIDE OF THE POSSIBILITY THAT, FOR WHATEVER REASON, EXCESSIVE MECHANICAL FORCE WAS APPLIED, WE CANNOT DISCERN ANY OTHER ROOT OR UNDERLYING CAUSE FOR THE DEVICE'S CONDITION. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ARTHROSCOPIC KNEE REPAIR, A PORTION OF THE DISTAL TIP OF AN INTRAFIX TIBIAL SHEATH INSERTER BROKE OFF INTO THE BODY. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAFIX TIBIAL SHEATH INSERTER ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1