BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTB TIGHTROPE

    MDR report key: 3003328 · Received March 14, 2013

    Report

    Report Number
    1220246-2013-00035
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 7, 2008
    Report Date
    February 14, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    K112990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE 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 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE IS THAT THE IMPLANT MAY HAVE CRACKED OR BROKEN WHEN IT WAS INITIALLY INSERTED AND WENT UNNOTICED BY THE SURGEON AND/OR PATIENT POST-OP NON-COMPLIANCE. PRODUCT DIRECTIONS FOR USE STATES, POST-OPERATIVELY AND UNTIL BONE HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. ANY DECISION TO REMOVE THE DEVICE SHOULD TAKE INTO CONSIDERATION THE POTENTIAL RISK TO THE PATIENT OF A SECOND SURGICAL PROCEDURE. DEVICE REMOVAL SHOULD BE FOLLOWED BY ADEQUATE POSTOPERATIVE MANAGEMENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BTB TRANSPLANT WAS INSERTED WHICH HAD TO BE REMOVED AT END OF 2009 BECAUSE OF FURTHER COMPLICATIONS. PRIOR CASE HISTORY NOT REPORTED TO ARTHREX UNTIL THIS NEW ISSUE ON (B)(6) 2013: THE PATIENT HAD PAIN, 8 MONTHS POST-OP AND AN MRI WAS DONE. IT SHOWED THAT THE PIN FROM THE ORIGINAL BIO-TRANSFIX HAD BROKEN. PIECES WERE REMOVED IN A REVISION SURGERY. THE PATIENT CONTINUED TO HAVE PAIN. A 3RD POST-OP VISIT SHOWED FRAGMENTS WERE STILL LEFT, AS WELL AS WIDENED BONE TUNNELS RESULTING IN FILLING OF THE BONE TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107665 BTB TIGHTROPE PIN, FIXATION, SMOOTH HTY ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1351LB, BIO_TRANSFIX, LOT 114370