BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIM-IT DRILLPIN, 2.0MM X 100MM, KIT

    MDR report key: 1062059 · Received June 5, 2008

    Report

    Report Number
    1220246-2008-00099
    Event Type
    Injury
    Date Received
    June 5, 2008
    Date of Event
    March 3, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE CUSTOMER AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. ADD'L INFO REC'D FROM THE SURGEON'S OFFICE REVEALED THE PT ALSO PRESENTED ISSUES WITH THE ADD'L PINS IMPLANTED IN THE OTHER TOES. THE CONDITION REPORTED COULD BE RELATED TO AN ADVERSE PT REACTION TO ANY OF THE MATERIALS IMPLANTED. PROD DFU WARNS OF A POSSIBLE ALLERGIC REACTION TO THE IMPLANT MATERIALS. PT SENSITIVITY MUST ALWAYS BE CONSIDERED PRIOR TO IMPLANTATION. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. IF FURTHER INFO RELEVANT TO THE CAUSE OF THIS EVENT BECOMES AVAILABLE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS EVENT WAS REC'D FROM THE FDA, VIA COPY OF THE CUSTOMER'S SUBMISSION THROUGH THE MAUDE DATABASE. CUSTOMER REPORTED THAT POST OPERATIVELY, THE ABSORBABLE PIN AS DESCRIBED BY CUSTOMER "IN DIGIT 2ND LEFT" PRESENTED WITH DISCOLORATION UNDER THE TOENAIL AND TENDERNESS IN THE DIGIT. THIS REQUIRED ADD'L SURGERY TO REMOVE IT. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIM-IT DRILLPIN, 2.0MM X 100MM, KIT BIO-ABSORBABLE IMPLANT MAI ARTHREX, INC. NA 90201

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention