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

Model Number	2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a facility representative via phone that an ar-7220 fiberwire and needle broke inside the patient.The facility representative did not know how this occurred but stated the broken fragments remain in the patient.This was discovered during an amputation procedure on (b)(6) 2022.Facility representative also does not know how the case was completed but that it was completed successfully.

• Brand Name: 2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
• 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: 14269352
• Report Number: 1220246-2022-04818
• Device Sequence Number: 5158854
• Product Code: GAT
• UDI-Device Identifier: 00888867041486
• UDI-Public: 00888867041486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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: 05/31/2023
• Device Model Number: 2-0 FW BLUE W/ TPR 3/8CIR NEEDLE
• Device Catalogue Number: AR-7220
• Device Lot Number: 19640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/03/2022
• Date Device Manufactured: 09/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown