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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 sales representative reported via (b)(4) that an ar-1665bcsl 4.75 bc loop 'n' tack¿ tenodesis implant systems tip broke off.This occurred during a case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1665bcsl batch 15353002 was received for evaluation.Visual inspection noted that the received device's nitinol wire tip was broken off.Functional test pressing the button found no resistance.The most likely cause of the reported failure is user error, which may include excessive force, misalignment of the device during insertion, and/or contact with other instruments during use.

• 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: 22098830
• Report Number: 1220246-2025-02269
• Device Sequence Number: 8340333
• 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): 09/25/2025

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?: Yes
• 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: 09/19/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/25/2025
• 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