MAUDE Adverse Event Report: ARTHREX, INC. INTERNAL BRACE LIGAMENT REPAIR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1688-CP
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Additional 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 remained in the patient 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.A likely cause of this type of event is a reaction of the patient to the material(s) implanted.Product directions for use warns of 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.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.Part remains in patient.
Event or Problem Description
It was reported that patient had previously contacted arthrex prior to a planned surgery to obtain the material composition of the ar-1688-cp which was provided to her.The arthrex record reference number for this inquiry was cc94565.Patient has now reported that she had undergone right hallux varus correction surgery on (b)(6) 2016.Patient was unable to locate any allergist or dermatologist who was able to do testing for the bovine collagen coated fibertape used in the ar-1688-cp and chose to proceed with the surgery without allergy testing.Patient reports that beginning two weeks post-op, she was experiencing hives with single hives appearing prior to two weeks post-op.Patient reports that the hives are now on her legs, thigh, chest, back and elsewhere.In addition, patient reports that after the wrapping and sutures came out two weeks post-op her big toe was angled outwardly in the same way as it did prior to surgery.Patient states the surgeon did not explain why the procedure did not work and only indicated to her that it was unfortunate.Additional information obtained 10/12/2016: patient has provided an update and has reported that her hives are now gone.She had scheduled surgery to remove the implants due to the hives but has now cancelled that surgery.Patient has chosen to wait and see if her hallux varus gets any worse as she prefers not to have a revision using cadaver tendon.

• Brand Name: INTERNAL BRACE LIGAMENT REPAIR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6021291
• Report Number: 1220246-2016-00419
• Device Sequence Number: 16227423
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 10047541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other