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

Model Number	SUTURELASSO, 90 DEGREE STRAIGHT
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 rotator cuff surgery the thin plastic layer/protective cover of the lasso came loose.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is confirmed.-upon visual inspection, noted that the shrink tube of the closed wire loop, stranded, shrink tube was broken, of the suturelasso¿ sd, 90° straight.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to the user error of the device due to excessive force used during the passing of the suture through tissue.

• 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: 22494880
• Report Number: 1220246-2025-02853
• Device Sequence Number: 4145927
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: (01)00888867031517(11)240801(17)290731(10)4179150546
• 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): 09/11/2025

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: SUTURELASSO, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 4179150546
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown