MAUDE Adverse Event Report: ARTHREX, INC. SUTURE PASSING WIRE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURE PASSING WIRE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Visual evaluation identified that all four devices had the nitinol wire loop had broken off from the distal end.The wire loop was found to be frayed as well.Due to the fractured state of the device, functional testing to determine straight pull force could not be determined.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces on the wire loop.
Event or Problem Description
It was reported that when the surgeon attempted to pass the 1.3mm tape, 3 ar-1255-18, suture loops were torn off in quick succession.The surgeon used a new product to finish the case.No adverse effect on patient.

• Brand Name: SUTURE PASSING WIRE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19563742
• Report Number: 1220246-2024-06030
• Device Sequence Number: 15009813
• Product Code: LXH
• UDI-Device Identifier: 00888867006539
• UDI-Public: 00888867006539
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 06/18/2024

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 Expiration Date: 09/30/2025
• Device Model Number: SUTURE PASSING WIRE
• Device Catalogue Number: AR-1255-18
• Device Lot Number: 11937535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown