MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 2.9 BC PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	LNT IMPLANT SYSTEM, 2.9 BC PUSHLOCK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/29/2025, a sales representative reported via phone that an ar-1665bcpl 2.9 bc loop 'n' tack¿ tenodesis implant systems swift stitch did not advance.This occurred before use out of the box during a biceps tenodesis procedure on (b)(6) 2025.The procedure continued with a tenotomy performed.There was no delay in the case.There was no harm on the patient.Additional information has been requested.Additional information was provided on 09/29/2025 where it was reported that due to the defective kit first and bicep pathology, a tenotomy was decided to be preformed.
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 returned device (if available), photographs, videos, event description, and any additional field input¿arthrex has determined that the most likely cause is attributed to a use-related condition, such as insufficient advancement of the control mechanism, which may have resulted in improper operation of the device.This root cause could not be confirmed, as the device was not returned for evaluation.

• Brand Name: LNT IMPLANT SYSTEM, 2.9 BC PUSHLOCK
• 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: 23292452
• Report Number: 1220246-2025-04581
• Device Sequence Number: 11961610
• Product Code: MAI
• UDI-Device Identifier: 00888867367258
• UDI-Public: (01)00888867367258(11)240729(17)260630(10)15293813
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• 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): 01/30/2026

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: 06/30/2026
• Device Model Number: LNT IMPLANT SYSTEM, 2.9 BC PUSHLOCK
• Device Catalogue Number: AR-1665BCPL
• Device Lot Number: 15293813
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown