BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TIGHTROPE 1.1 MM, DISPOSABLE

    MDR report key: 1820017 · Received August 30, 2010

    Report

    Report Number
    1220246-2010-00169
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    PMA / PMN Number
    K090107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION INCLUDING PATIENT WEIGHT AND CURRENT CONDITION WAS REQUESTED BUT NOT PROVIDED. 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/IS EXPECTED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. AS REPORTED AND BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDES POOR PLACEMENT IN THE BONE, SUTURE ABRASION, KNOT FAILURE, AND/OR PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL AND RESUMING WEIGHT-BEARING TOO EARLY, POSSIBLY IN THIS CASE DUE TO HAVING SURGERY ONE MONTH LATER ON THE OPPOSITE FOOT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. REQUESTED, BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED APPROXIMATELY 2.5 MONTHS POST OP. THE ORIGINAL PROCEDURE WAS A LAPIDUS BUNIONECTOMY. ONE MONTH LATER, THE PATIENT HAD A BUNION SURGERY ON THEIR OTHER FOOT. THEN APPROXIMATELY 6 WEEKS LATER, THE PATIENT PRESENTED WITH A COMPLAINT THAT THE FIRST (ORIGINAL) FOOT DID NOT LOOK RIGHT; IT APPEARED THE BUNION HAD RETURNED. X-RAY SHOWED A FRACTURED 2ND METATARSAL; THE BUTTON PART OF THE DEVICE HAD COME THROUGH THE BONE. A REVISION WAS PERFORMED, THE ORIGINAL DEVICE WAS EXPLANTED, AND DIFFERENT BUNION PROCEDURE WAS COMPLETED. THE PATIENT WAS BELIEVED TO HAVE BEEN POST-OP COMPLIANT. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TIGHTROPE 1.1 MM, DISPOSABLE WASHER, BOLT NUT HTN ARTHREX, INC. 253868

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other