MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK; NON-DEGRADABLE FIXATN FASTENER

Model Number	LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
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
On 05/09/2025, a representative reported via (b)(4) that an ar-1665bcsl 4.75 bc loop 'n' tack¿ tenodesis implant system broke off during suture passage.This occurred during a rotator cuff repair.When the retractable tip got stuck on the scope sheath, it broke off when trying to remove it.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to interference with another instrument.

• Brand Name: LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22236757
• Report Number: 1220246-2025-02490
• Device Sequence Number: 8186171
• Product Code: MAI
• UDI-Device Identifier: 00888867367265
• UDI-Public: 00888867367265
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• 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): 10/13/2025

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: LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL
• Device Lot Number: 15353002
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown