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)(6) 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 diffrent 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; prying/leveraging the device during insertion.

• 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: 21619664
• Report Number: 1220246-2025-00982
• Device Sequence Number: 18270241
• 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