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

Model Number	IMPLANT SYSTEM, SUTURELOC
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/23/2025, it was reported by a sales representative via (b)(4) that an ar-4551 sutureloc meniscal root repair kit experienced an implant-related issue.The device was implanted on (b)(6) 2025 to repair the lateral meniscal root.The procedure was completed without difficulty or complication.Thirteen weeks post-implantation, the patient returned to the clinic reporting knee stiffness.An attempted joint manipulation in the office was not well tolerated by the patient.On (b)(6) 2025, a manipulation under anesthesia and knee arthroscopy were performed.During the arthroscopy, one of the repair sutures (blue) from the ar-4551 device was found to be loose.Upon probing, the tail of the blue suture was observed within the joint, indicating that the knotless mechanism of the device was not maintaining tension on the blue repair suture.The white repair suture appeared to retain appropriate tension.The loose blue suture was partially removed, while the white suture was left intact.Additional information was received on 10/28/2025: the patient underwent joint manipulation in the office on (b)(6) 2025.The patient is doing well after the manipulation under anesthesia and knee arthroscopy on (b)(6) 2025, but is experiencing some stiffness.
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 the most likely cause.The most likely cause is attributed to patient-specific postoperative factors resulting in loss of suture tension.This determination is consistent with dfu-0386-eo, revision 3, warning 8, which states: ¿postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to 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: 23463330
• Report Number: 1220246-2025-04974
• Device Sequence Number: 18709424
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: (01)00888867425316(11)250304(17)291130(10)15399007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IMPLANT SYSTEM, SUTURELOC
• Device Catalogue Number: AR-4551
• Device Lot Number: 15399007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown