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	01/28/2025
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, it was reported by a sales representative via phone that an ar-4551 sutureloc kit implant loosened after final tension and implementation of the knee.This occurred during use in a meniscus root repair with no patient effect.Case was completed using swivellock to secure final fixation.10 minutes added to case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded that the most likely cause of the reported failure is an error, specifically improper surgical technique with the device.

• 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: 21399575
• Report Number: 1220246-2025-00451
• Device Sequence Number: 9345271
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: 00888867425316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/23/2025

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: IMPLANT SYSTEM, SUTURELOC
• Device Catalogue Number: AR-4551
• Device Lot Number: 15349043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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