MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery while piercing the labrum the device broke off.Per complaint reporter there was no harm for patient, operator or third party.No further information received.Update 08-apr-2026: further information was provided that the reported issue occurred during a labrum stabilisation.It was further confirmed that the broken part was retrieved out of the patient and the surgery was finished successfully with a new device with the same part number.

• Brand Name: SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
• 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: 24926693
• Report Number: 1220246-2026-02297
• Device Sequence Number: 13428899
• Product Code: LXH
• UDI-Device Identifier: 00888867031425
• UDI-Public: (01)00888867031425(11)250601(17)300531(10)5126159746
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/14/2026

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, 25 DEGREE TIGHT CURVE LEFT
• Device Catalogue Number: AR-4068-25TL
• Device Lot Number: 5126159746
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/31/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown