BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOINTRAFIX TAPERED SCREW, 7-9 MM X 30 MM

    MDR report key: 2233397 · Received September 2, 2011

    Report

    Report Number
    1221934-2011-00309
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K032167
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DAYS HAVE NO PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE RETURN STATUS REQUEST, THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, 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.

    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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, THE BIOINTRAFIX FIXATION SCREW BROKE APART WHILE THE SURGEON WAS DRIVING INTO THE BONE TUNNEL. A PORTION OF THE BREAK CAME OUT OF THE TUNNEL, AND A PORTION REMAINED IN THE TUNNEL; THE SURGEON REMOVED THE REMAINING PORTION AND COMPLETED THE REPAIR SUCCESSFULLY USING ANOTHER SAME TYPE OF FIXATION SCREW WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT: THE PROCEDURE WAS EXTENDED BY 45 MINUTES BECAUSE OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX TAPERED SCREW, 7-9 MM X 30 MM SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA 3506764

    Patients

    Seq Age Sex Outcome Treatment
    1