MAUDE Adverse Event Report: ARTHREX, INC. FIBERWIRE PBP #2, 1 BLUE, 1 WHITE/BLACK; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-7201
Health Effect - Clinical Codes	Complaint, Ill-Defined (2331); Joint Swelling (2356)
Date of Event	10/19/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is the first of two submissions for the same patient event.The other is 1220246-2017-00057 ((b)(4)).The device was not returned 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.Lot number was not provided so device history record review cannot be performed.A possible cause of this type of event maybe a reaction of the patient to the material(s) implanted or used during the implant procedure.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 materials must be considered prior to implantation.Part remains in patient.
Event or Problem Description
It was reported by the patient that approx.6 months after implantation on (b)(6) 2012 of the ar-1929sf-3 ((b)(4)) and ar-7201 ((b)(4)) into patient´s shoulder, a reaction with swollen joints (hip, knee, shoulder), pain and general indisposition occurred.No further details given at this time.

• Brand Name: FIBERWIRE PBP #2, 1 BLUE, 1 WHITE/BLACK
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6401990
• Report Number: 1220246-2017-00058
• Device Sequence Number: 528522
• Product Code: GAT
• UDI-Device Identifier: 10888867041285
• UDI-Public: 10888867041285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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 Catalogue Number: AR-7201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/14/2017
• 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