BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERTAPE

    MDR report key: 3203688 · Received July 3, 2013

    Report

    Report Number
    1220246-2013-00116
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K052776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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 PART REMAINS IN THE PATIENT AND CANNOT BE 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 NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AS STATED IN THE EVENT, THAT THREE MONTHS POST-OP, THERE WAS A STERILE BREAKDOWN OF THE SKIN OVER THE FIBER TAPE KNOT STACK, A POSSIBLE ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. ALSO THE DIRECTIONS FOR USE ((B)(4)) STATES: "USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURES AND TECHNIQUES INVOLVING NON-ABSORBABLE SUTURES BEFORE EMPLOYING ARTHREX FIBERWIRE OR ARTHREX 100% UHMWPE (ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE) SUTURE FOR WOUND CLOSURE, AS THE RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED." 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. PART REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SURGEON THAT THE PATIENT HAD A REACTION AT THE SITE OF THE FIBERTAPE KNOT STACK CAUSING A STERILE BREAKDOWN OF THE SKIN 3 MONTHS POST-OP. THE PROCEDURE, AC RECONSTRUCTION. THE SURGEON WASHED OUT AND CLOSED THE WOUND. ALSO USED IN PROCEDURE WAS (B)(4), LOT# 09925 (AC TIGHTROPE KIT). THE PATIENT IS DOING WELL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305350 FIBERTAPE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other