MAUDE Adverse Event Report: ARTHREX, INC. #2 TW,38" W/2 TPR NDLS; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	#2 TW,38" W/2 TPR NDLS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2023
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) 2023, it was reported by an arthrex employee via email that an ar-7205t tigerwire with 2 tapered needles was used in a spine surgery on (b)(6) 2023 and postoperative ct scans confirmed the presence of metal fragments in the patient's body.The surgeon suspects that the product is contaminated with a piece of metal.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is not confirmed.Visual evaluation of the needles did not find any issues.The suture's overall length was cut on each needle and no issues were found on the sutures.No problem found.

• Brand Name: #2 TW,38" W/2 TPR NDLS
• 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: 16386001
• Report Number: 1220246-2023-06299
• Device Sequence Number: 5705880
• Product Code: GAT
• UDI-Device Identifier: 00888867041332
• UDI-Public: 00888867041332
• 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,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: #2 TW,38" W/2 TPR NDLS
• Device Catalogue Number: AR-7205T
• Device Lot Number: 26251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown