MAUDE Adverse Event Report: ARTHREX, INC. SUTURESNARE, 90 STRAIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURESNARE, 90 STRAIGHT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/27/2025, it was reported by a arthrex subsidiary employee via (b)(4) that an ar-6060-90 suturesnare tip was deformed and wire could not be retracted.This occurred during use in a case with no patient harm.This case was completed by using another product of of competing company.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the suturesnare¿ suture passer, 90°, identified that the tip of the nitinol snare was pulled in and stuck on the tip of the suturesnare.Functional testing was performed, and the wire was able to retract, pushing forward the actuator.However, due to deformation, the snare tip was stuck on the shaft's tip.The most likely cause of the reported failure can be attributed to user error of the device due to applying excessive mechanical forces on the actuator, and/or upon insertion.

• Brand Name: SUTURESNARE, 90 STRAIGHT
• 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: 21344330
• Report Number: 1220246-2025-00329
• Device Sequence Number: 15412994
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: (01)00888867204638(11)240123(17)281231(10)15196736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: SUTURESNARE, 90 STRAIGHT
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 15196736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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