MAUDE Adverse Event Report: ARTHREX, INC. 2-0 FW BLUE W/ TPR 3/8CIR NEEDLE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Skin Discoloration (2074); Swelling (2091); Discomfort (2330)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported that after a patient had an initial knuckle replacement procedure on (b)(6) 2018, they immediately started experiencing an adverse reaction.The patient is highly sensitive to nickle.No arthrex parts were implanted during the first procedure.On (b)(6) 2019 the patient had a hardware removal, and the surgeon implanted an arthrex fiberwire to heal the original bone fracture.After the revision procedure, the patient is still experiencing pain and discomfort.The finger is swollen and inflamed, and there is some discoloration with very little range of motion of the finger.X-rays have been taken, and the patient has a weekly follow-up visit with their surgeon.Additional information has been requested.Additional information received on 1/23/2019: the facility confirmed that the original and revision procedure were performed by the same surgeon.During the initial procedure that took place on (b)(6) 2018 a competitor's dentalwire was implanted.Soon after having the dentalwire implanted, the patient was experiencing swelling, pain and discomfort around the surgical site.A revision procedure was scheduled to remove the dentalwire.During the revision procedure, ar-7220 (lot: 07851) was implanted.The patient is still experiencing swelling, pain and discomfort.The physician is planning to contact an allergist to perform further testing.

• Brand Name: 2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344314
• Report Number: 1220246-2019-00896
• Device Sequence Number: 19299523
• Product Code: GAT
• UDI-Device Identifier: 00888867041486
• UDI-Public: 00888867041486
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
• Device Catalogue Number: AR-7220
• Device Lot Number: 07851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/15/2019
• 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