MAUDE Adverse Event Report: Arthrex, Inc. SUTURELASSO, 45 DEGREE CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 45 DEGREE CURVE RIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-sep-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-4068-45r 45° curve right suturelasso tip became bent when using the instrument for the second anchor.The surgeon attempted to straighten it using a kelly clamp, and when reintroducing the device to pass through the labrum, the tip broke.This was discovered during a shoulder instability repair with knotless pushlock procedure with no patient harm.No fragments remained in the patient.There was no delay to the procedure, and no additional anesthesia was required.The case was completed with another suturelasso.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTURELASSO, 45 DEGREE CURVE RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50869611
• Report Number: 1220246-2026-04869
• Device Sequence Number: 9425953
• Product Code: LXH
• UDI-Device Identifier: 00888867031494
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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, 45 DEGREE CURVE RIGHT
• Device Catalogue Number: AR-4068-45R
• Device Lot Number: 5027156438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown