MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE; PIN, FIXATION, SMOOTH

Catalog Number AR-1588T

Device Problem Insufficient Information (3190)

Patient Problem Itching Sensation (1943)

Event Date 03/26/2015

Event Type  Injury  

Event Description

It was reported by the patient that he had a left acl reconstruction surgery on (b)(6) 2015.He stated that the op report mentions the use of an arthrex tightrope button.A few weeks after the surgery patient began to experience hives and itching on his left leg which was intermittent.Then after a few more weeks, patient began to experience hives and itching all over his body which was also intermittent (appearing and disappearing randomly).Patient's regular physician prescribed a full course of prednisone, which has been completed.After that the patient's hives and itching are no longer intermittent, they are now constant.Physician has instructed patient to begin taking antihistamines to see if that will resolve the issue.If issue is not resolved with the antihistamines, physician will do allergy testing for the implants used during his surgery.No other details available at this time.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, 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 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.Based on the information provided, the most likely cause(s) of this event is an 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.If additional relevant information is received, a follow-up report will be submitted.Part remains in the patient.

• Brand Name: ACL TIGHTROPE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4784457
• MDR Text Key: 21838244
• Report Number: 1220246-2015-00132
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-1588T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other