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	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/15/2025, a sales representative reported via phone that an ar-4551 sutureloc, meniscal root repair kit, had an issue during a meniscal root repair procedure on (b)(6) 2025.When the surgeon was trying to insert the implant, it would not seat into the tibia.The implant was removed from the patient in one piece, nothing broke, and there was no harm.Another ar-4551 sutureloc, meniscal root repair kit, with a different lot number, 15353524, was opened to complete the procedure successfully.The complaint device was discarded, and no pictures were taken.The case was not delayed, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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 the complaint device was not received for evaluation.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 of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22700924
• Report Number: 1220246-2025-03220
• Device Sequence Number: 21069025
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: (01)00888867425316(11)250514(17)300331(10)15436079
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 15436079
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown