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	03/29/2022
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
(b)(6) 2022, it was reported by a sales representative via sems that an ar-7230-01 fiberwire® #4-0, braided polyblend suture, blue, with tapered point needle had an issue.During a wound exploration possible nerve repair (b)(6) 2022, when working on hand, approximating the tendon back together, when pulling suture through hand, the needle detached from suture mid pass.The piece broke off inside the patient and was retrieved.The case was completed successfully with no impact to the patient.

• 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: 14135815
• Report Number: 1220246-2022-04747
• Device Sequence Number: 11989291
• Product Code: GAT
• UDI-Device Identifier: 00888867041615
• UDI-Public: 00888867041615
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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: 03/31/2026
• Device Model Number: 4-0 FW,18" W/TPR NDL 12.3 MM
• Device Catalogue Number: AR-7230-01
• Device Lot Number: 24555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown