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	11/07/2025
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 11/07/2025, a sales representative reported via phone that an ar-4551 sutureloc meniscal root repair kit malfunctioned during a meniscal root repair procedure.The issue occurred during the final tensioning step, where the white and blue sutures failed to lock into the implant or maintain tension.Subsequently, the sutures were pulled all the way out.The case was completed by removing the whole implant and using a replacement ar-4551 kit from a different lot, which functioned as intended.The incident resulted in a 30-minute delay to the case; however, it remains uncertain whether additional anesthesia was administered as a result of the delay.Bone preparation for implant insertion was performed using the ar-1610h meniscus root marking hook and the drill pin included in the kit.The bone quality was described as good and young.No patient harm was reported.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged sutureloc¿ with sutures (batch 15461887) was received for evaluation.Visual inspection noted that only the sutures were returned for evaluation.Functional testing could not be performed due to the incomplete and damaged condition of the returned components.The most likely cause of the observed condition is attributed to use-related factors, such as incomplete implant seating, suture misrouting/twist/crossing, or over-tensioning.The complaint allegation is confirmed.Refer to the investigation photos.

• 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: 23660025
• Report Number: 1220246-2025-05232
• Device Sequence Number: 10055194
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: (01)00888867425316(11)250707(17)300531(10)15461887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/04/2026

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: 15461887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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