MAUDE Adverse Event Report: ARTHREX, INC. 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	09/21/2020
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.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent a trapezium procedure (b)(6) 2020.During the procedure the surgeon used arthrex, ar-7250 fiberwire sutures.Since the procedure the incision opened up and the patient developed an infection which required treatment.The patient has been having ongoing issues since surgery which include pain, itching, redness and swelling.Patient has had issues in past surgeries with sutures/ soft plastics.The current issues are similar to those experienced in the past.

• Brand Name: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11045098
• Report Number: 1220246-2020-02411
• Device Sequence Number: 1193599
• Product Code: GAT
• UDI-Device Identifier: 00888867041851
• UDI-Public: 00888867041851
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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 Model Number: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• Device Catalogue Number: AR-7250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/21/2020
• 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