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	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
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 (b)(6) 2025, it was reported by a distributor via (b)(4) that (2) ar-1322-752sf small bone fastak¿ suture anchor with 2-0 fiberwire did not release correctly.This occurred during repair of ulnar collateral ligament when the first anchor did not release correctly.It embedded partially.The surgeon had to finish anchoring it in using a mallet.This did not work and she then had to cut it out and try again at a different site.A new suture anchor was opened and this one also did not deploy correctly.It cut both the sutures when she went to release it.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion and/or incorrect release technique.Dfu for this device states the following: 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.

• 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: 21619577
• Report Number: 1220246-2025-00981
• Device Sequence Number: 6668482
• Product Code: MBI
• UDI-Device Identifier: 00888867010130
• UDI-Public: (01)00888867010130(11)230913(17)280831(10)15141190
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: SUTR ANCH,FASTAK,SM BONE
• Device Catalogue Number: AR-1322-752SF
• Device Lot Number: 15141190
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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