BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIM-IT DRILL PIN 2MM X 100MM

    MDR report key: 1860875 · Received October 7, 2010

    Report

    Report Number
    1220246-2010-00190
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    K050259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. ALLERGIC-LIKE REACTIONS TO PLA MATERIALS (PLLA, PLDLA) HAVE BEEN REPORTED. THESE REACTIONS HAVE SOMETIMES NECESSITATED THE REMOVAL OF THE IMPLANT. PRODUCT DIRECTIONS FOR USE (DFU-0107) WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT'S SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED POST OP ABSCESS, INFECTION AND BONE EROSION. ORIGINAL DATE OF SURGERY (B)(6)2009. IN (B)(6) 2009 SIGNS OF REJECTION IN THE 2ND TOE WERE SUCCESSFULLY TREATED WITH ANTIBIOTICS AND REST. (B)(6) 2010, PATIENT PRESENTED WITH FURTHER SWELLING. SECOND SURGERY (B)(6)2010; BONE CORTEX HAD ERODED; PIECES OF IMPLANT WERE STILL IN BONE; THOSE WERE REMOVED. NO BACTERIA FOUND IN THE INFECTION. BONE GRAFTS WERE IMPLANTED TO FILL IN VOID OF ABSCESS. THE 3RD TOE HAS NOT HAD ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIM-IT DRILL PIN 2MM X 100MM PIN, FIXATION, SMOOTH HTY ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other