BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK NITINOL GUIDE WIRE, 1.1MM X 38. CM (15')

    MDR report key: 4993466 · Received August 11, 2015

    Report

    Report Number
    1221934-2015-00902
    Event Type
    Injury
    Date Received
    August 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT; WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. HOWEVER ONE POSSIBLE ROOT CAUSE IS THE COMPLAINT DEVICE GUIDE WIRE WAS PLACED IN A LOCATION WHERE THE SCREW WAS ABLE TO MAKE CONTACT WITH IT DURING INSERTION, RESULTING IN THE GUIDE WIRE BREAKING. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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

    ACL RECONSTRUCTION BILATERAL, DATE OF EVENT IS SOMEWHERE IN (B)(6) OR (B)(6). THE SURGEON CONTACTED THE PRODUCT SPECIALIST AND REPORTED THAT WHILE INSERTING THE ACL SCREW, THE WIRE SEEM TO GET STUCK. WHILE TRYING TO REMOVE WIRE, THE WIRE SNAPPED ON BOTH SIDE. THE PIECE OF THE WIRE HAD TO REMAIN IMPLANTED IN THE PATIENT. ONE MONTH LATER THE SURGEON NEEDED TO REVISIT DUE TO MIGRATION OF THE WIRE INTO JOINT. SURGEON REMOVED THE WIRE. PRODUCT SPECIALIST WAS NOT PRESENT DURING THE SURGERY. PATIENT WAS FINE POST-SURGERY. NO ADVERSE EVENT TO PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AFFILIATE VIA EMAIL ON 07-20-2015. THIS CASE WAS DONE A COUPLE OF MONTHS BACK AND THE SURGEON SPOKE TO ME ABOUT THE ISSUES ON (B)(6). THE SURGEON WAS PERFORMING BILATERAL ACL RECONSTRUCTIONS ON A YOUNG FIT PATIENT. DURING SCREW INSERTION INTO THE FEMUR, THE GUIDE WIRE BECAME STUCK. DURING HIS EFFORTS TO REMOVE THE GUIDE WIRE, THE WIRE BROKE OFF IN THE FEMORAL TUNNEL. THIS HAPPENED ON BOTH FEMURS AND BOTH (2) WIRES WERE BROKEN DURING REMOVAL. THE SURGEON DECIDED THAT THE WIRE FRAGMENTS WOULD HAVE TO REMAIN IN-SITU AS REMOVAL WOULD HAVE BEEN TOO DIFFICULT. A COUPLE OF WEEKS LATER, THE ONE FRAGMENT HAD MIGRATED AND NEEDED TO BE REMOVED SURGICALLY. SEE ASSOCIATED MEDWATCH # 1221934-2015-00901.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527539 MITEK NITINOL GUIDE WIRE, 1.1MM X 38. CM (15') ARTHROSCOPIC ACL INSTRUMENT FZX DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention