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	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/10/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-4068-45l suturelasso broke.This occurred during a case when passing the right 45° suture into the patient's labrum, the tip crumpled and stuck in the cannula.In an attempt to remove the dented lasso from the cannula, it broke.
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.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure.The most likely cause of reported failure of the ar-4068-45r suturelasso appears to be due to mechanical stress during use, potentially compounded by improper handling or technique.The tip of the device crumpled while passing the suture into the labrum, suggesting that excessive force or misalignment may have occurred.Additionally, the surgeon noted that the suture loop was crushed during tendon drilling, despite minimal applied force, which may indicate material fatigue or a structural weakness in the loop.The absence of fragments and the loop breaking while being untied further support the likelihood of stress-induced failure.The complaint allegation was confirmed based on the customer's attached picture of a suture lasso sd 45° with the curved tip broken off.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, g3.Additional information was provided on 08/12/2025 where it was stated this case occurred during shoulder surgery for glenohumeral instability.It happened when drilling the tendon.The surgeon said that he did not use much force to drill the tendon, which ended up crushing the suture loop.There were no fragments, mainly because the loop broke when it was untied.Another suture loop was opened.
Event or Problem Description
Additional information was provided on 08/12/2025 where it was stated this case occurred during shoulder surgery for glenohumeral instability.It happened when drilling the tendon.The surgeon said that he did not use much force to drill the tendon, which ended up crushing the suture loop.There were no fragments, mainly because the loop broke when it was untied.Another suture loop was opened.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is product misuse.Specifically, the lasso tip became damaged and stuck in the cannula.In an attempt to remove the dented lasso from the cannula, it broke.The complaint allegation was confirmed based on the customer's attached picture of a suture lasso sd 45° with the curved tip broken off.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21265392
• Report Number: 1220246-2025-00106
• Device Sequence Number: 4275904
• Product Code: LXH
• UDI-Device Identifier: 00888867031470
• UDI-Public: 00888867031470
• 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
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2025

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, 45 DEGREE CURVE RIGHT
• Device Catalogue Number: AR-4068-45R
• Device Lot Number: 3241134603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 08/12/2025; 09/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 08/06/2025; 08/15/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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