MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,FASTAK,SM BONE; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH,FASTAK,SM BONE
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 19-jan-2026, a competent authority reported via email that an ar-1322-752sf small bone fastak suture anchor was deployed but did not remain docked in the bone.The issue occurred during a procedure on (b)(6) 2026.No patient harm was reported.Additional information was received on 23-jan-2026: this was discovered during a ucl thumb procedure.There were two ar-1322-752sf small bone fastak suture anchor that were removed from the patient as the anchors pulled out of the bone.A replacement ar-1322-752sf small bone fastak suture anchor was used to complete the case.There was no case delay or added anesthesia administered.No adverse effects were reported.
Additional Manufacturer Narrative
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.Neither the method used to prepare the bone nor the bone quality encountered during the procedure were provided.The most likely attributed to use-related factors such as improper bone preparation, misaligned insertion, or incomplete bone preparation at the insertion site.Per dfu-0054-eo revision 7, c.Contraindications, 7: the use of this device may not be suitable for patients with insufficient or immature bone.The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature.E.Warnings: 6: preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.G.Precautions, 3: fastak suture anchors only: stopping and restarting the drill may result in excess torque being applied to the implant, which may cause the device to fail.

• Brand Name: SUTR ANCH,FASTAK,SM BONE
• 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: 24299034
• Report Number: 1220246-2026-00486
• Device Sequence Number: 9435563
• Product Code: MBI
• UDI-Device Identifier: 00888867010130
• UDI-Public: (01)00888867010130(11)231204(17)281130(10)15175427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K971723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: SUTR ANCH,FASTAK,SM BONE
• Device Catalogue Number: AR-1322-752SF
• Device Lot Number: 15175427
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown