MAUDE Adverse Event Report: ARTHREX, INC. 4-0 FW,18" W/TPR NDL 12.3 MM; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	4-0 FW,18" W/TPR NDL 12.3 MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via email that an ar-7230-01 fiberwire is not sticking.This occurred during a finger operation, the surgeon used it to suture a tendon but couldn't use it because the needle would not stick.The case was completed using a new product, there was no patient effect reported.Additional information provided 11/02/2021: doctor opened the new ar-7230-01 and was able to fix it safely.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-7230-01 was received for investigation.Inspection that approximately 11.24mm of suture was returned attached to one suture needle.The remaining portion of the ar-7230-01 was not returned for analysis.No damage was present to the needle, although fraying was observed at the end of the suture fragment.The cause remains undetermined, although probable causes can be attributed to user-applied mechanical forces or interference between the suture and a sharp edge of bone/other instrumentation.

• Brand Name: 4-0 FW,18" W/TPR NDL 12.3 MM
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13152459
• Report Number: 1220246-2022-04218
• Device Sequence Number: 19756961
• Product Code: GAT
• UDI-Device Identifier: 00888867041615
• UDI-Public: 00888867041615
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 4-0 FW,18" W/TPR NDL 12.3 MM
• Device Catalogue Number: AR-7230-01
• Device Lot Number: 22716
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown