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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-dec-2025, a sales representative reported via email that an ar-1665bcsl-39 3.9 bc loop 'n' tack tenodesis implant system experienced an issue during insertion.When the surgeon advanced the anchor through the passport cannula to the bone, the eyelet had broken off from the threads of the inserter.The eyelet and anchor were promptly removed from the patient.A 4.75 mm swivelock anchor was then opened, and the site was re-punched without issues.The case was delayed two minutes from the surgical time.This was discovered during a slap repair with a biceps tenodesis procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 22-dec-2025: an additional two minutes of anesthesia were administered.No adverse effects were reported in relation to the event.The surgical technician confirmed that all components were retrieved from the patient, as the full length of the inserter threads and a complete anchor eyelet were identified.All fragments were accounted for.
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.-complaint allegation is not confirmed.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is attributed to user error, due to improper surgical technique associated with the use of the device.There was no evidence to indicate a device performance issue or device malfunction.

• 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: 23988327
• Report Number: 1220246-2026-00084
• Device Sequence Number: 18820722
• Product Code: MAI
• UDI-Device Identifier: 00888867367272
• UDI-Public: (01)00888867367272(11)250521(17)270331(10)15439537
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/20/2026

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 Model Number: LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL-39
• Device Lot Number: 15439537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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