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

Model Number	SUTURELASSO, 90 DEGREE STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-dec-2025, it was reported by a sales representative via (b)(4) that an ar-4068-90 suturelasso tip broke off during use.This was discovered during a shoulder bankart repair procedure with no patient harm.The broken fragment was retrieved from patient, and the case was finished successfully.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-4068-90, batch 5084158492, with a fractured tip.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is user-related, such as prying or using excessive force to leverage the device.

• Brand Name: SUTURELASSO, 90 DEGREE 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: 24039834
• Report Number: 1220246-2026-00166
• Device Sequence Number: 18760012
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: (01)00888867031517(11)250401(17)300331(10)5084158492
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 04/30/2026

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: SUTURELASSO, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 5084158492
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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