MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 4.75 BC KL SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	LNT IMPLANT SYSTEM, 4.75 BC KL SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/12/2024, a maude review notification was received via email that the metal tip of the loop 'n' tack swiftstitch suture passer from an ar-1665kbcsl lnt implant system broke and was directed in the inferior pouch.A separate inferior pouch axilla had to be established to remove the foreign metal body.This was discovered during a bicep tenodesis procedure on (b)(6) 2024.
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 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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: LNT IMPLANT SYSTEM, 4.75 BC KL SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21114477
• Report Number: 1220246-2025-09324
• Device Sequence Number: 20735621
• Product Code: MAI
• UDI-Device Identifier: 00888867367289
• UDI-Public: 00888867367289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 KL SWIVELOCK
• Device Catalogue Number: AR-1665KBCSL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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