MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via sems-06917603 that an ar-1665bcsl-39 3.9 bc loop 'n' tack¿ tenodesis implant systems anchor broke during insertion.This occurred during use in a rotator cuff repair.The bone was hard; it was prepped with the punch, and no pieces were left in the patient.
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 of the reported failure can be attributed to misaligned insertion, prying, and leveraging the device.

• Brand Name: LNT IMPLANT SYSTEM, 3.9 BC 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: 22349608
• Report Number: 1220246-2025-02692
• Device Sequence Number: 8519792
• Product Code: MAI
• UDI-Device Identifier: 00888867367272
• UDI-Public: (01)00888867367272(11)250121(17)260930(10)15375744
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192532
• 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): 10/14/2025

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 Expiration Date: 09/30/2026
• Device Model Number: LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL-39
• Device Lot Number: 15375744
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown