BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK BIO-INTRAFIX TIBIAL SHEATH - SMALL

    MDR report key: 3994121 · Received August 8, 2014

    Report

    Report Number
    1221934-2014-00332
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K032167
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICES ARE NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR EVALUATION TO DETERMINE IF THERE WERE ANY PRODUCT RELATED ISSUES THAT COULD HAVE LED TO THIS ADVERSE EVENT. MITEK IMPLANTS ARE PRODUCED STERILE AND VALIDATED. CLEANING AND STERILIZATION INSTRUCTIONS ARE PROVIDED IN THE IFU WITH MITEK REUSABLE INSTRUMENTS. HOWEVER, NO DETAILS ARE AVAILABLE REGARDING THE HOSPITAL¿S PRODUCT HANDLING, CLEANING AND STERILIZATION PROCEDURES. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED NON CONFORMANCE WITH NO LINK TO THIS COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED 1 DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, THE INFORMATION PROVIDED DOES NOT SUGGEST THE REPORTED FAILURE IS DUE TO THE IMPLANTS AND THEREFORE NO FURTHER ACTIONS ARE WARRANTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED IN FUTURE, THIS COMPLAINT WILL BE RE-EVALUATED. DEPUY 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 SALES REP REPORTED THAT APPROX. 2 WEEKS POST OP OF AN ACL REPAIR THE PATIENT DEVELOPED AN INFECTION. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014 TO REMOVE THE IMPLANTS AND THE GRAFT. THE AFFECTED KNEE WAS WASHED OUT AND THE PATIENT WILL HAVE TO HAVE THE ACL PROCEDURE REDONE IN 6 MONTHS¿ TIME. THE SALES REP REPORTED THE ORIGINAL SURGERY WAS COMPLETED USING THE BIOINTRAFIX TAPERED SCREW 6-8 X 30MM, THE BIOINTRAFIX SMALL SHEATH, 30MM, AND THE RIGIDFIX BIOCRYL FEMORAL 3.3MM ST CROSS PIN KIT. THE SALES REP REPORTED HE HAD NO FURTHER INFORMATION. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICES. THE SALES REP EMAILED ON (B)(6) 2014 TO REPORT THAT THE ORIGINAL ACL REPAIR WAS PERFORMED ON (B)(6)2014. SEE ASSOCIATED MED WATCH # 1221934-2014-00331 AND 1221934-2014-00333.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472237 MITEK BIO-INTRAFIX TIBIAL SHEATH - SMALL ACL IMPLANTS HWC DEPUY MITEK NA 3711558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention