MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, an arthrex subsidiary employee reported via (b)(4) that an ar-1318ft micro corkscrew suture anchor came loose from the stem and rolled away during use.No patient was affected.
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 allegation is confirmed based on photographic evidence of an ar-1318ft corkscrew®, batch 15442197, with a broken anchor.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 the misuse/mishandling of the device.The method of bone preparation and the quality of the bone encountered were not specified in the information provided.The most likely cause is attributed to use-related factors, including: improper bone preparation, deviation from the recommended surgical technique during the knotless mechanism conversion process, and/or application of excessive force during suture passing, tightening, or tensioning.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23360375
• Report Number: 1220246-2025-04765
• Device Sequence Number: 8809817
• Product Code: MBI
• UDI-Device Identifier: 00888867008519
• UDI-Public: (01)00888867008519(11)250527(17)300430(10)15442197
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K112237
• 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): 02/25/2026

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: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 15442197
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown