MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, SUTURELOC; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLANT SYSTEM, SUTURELOC
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-4551 sutureloc meniscal root repair kit experienced an issue during use.The anchor failed to partially set and could not be seated properly.During the attempt to pull the tensioning suture through the tibia, the suture snapped.The failed implant was removed from the patient.The procedure was completed using a replacement ar-4551 sutureloc meniscal root repair kit from a different lot.The only delay reported was the time required to open a new box.No additional anesthesia was administered.The patient's bone quality was assessed as average, and bone preparation was performed using the 2.4 mm drill included in the kit.The issue was discovered during a meniscal root repair procedure on (b)(6) 2025, with no reported patient harm.
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 the most likely cause.The most likely cause for the reported failure can be attributed to user error due to excessive force, tensioning, or prying/leveraging the device during insertion.Per the directions for use (dfu) dfu-0386-eo sutureloc¿ and sutureloc¿ implant system, section g, 1.Surgeons must apply their professional judgment when determining the appropriately sized device based on the specific indication, preferred surgical technique, and patient history.2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.

• Brand Name: IMPLANT SYSTEM, SUTURELOC
• 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: 23311112
• Report Number: 1220246-2025-04642
• Device Sequence Number: 14903319
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: (01)00888867425316(11)250714(17)300531(10)15466373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223284
• 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): 02/04/2026

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: IMPLANT SYSTEM, SUTURELOC
• Device Catalogue Number: AR-4551
• Device Lot Number: 15466373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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