MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-S-TAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,BIO-S-TAK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2025
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 sales representative via email that an ar-1934bcft-2-1 sutr anch, bio-s-tak was reported to have failed to deploy during use.This occurred on (b)(6) 2025 during a labral repair.The case was completed successfully using a new anchor and re-drilling the socket.There was case involvement.
Additional Manufacturer Narrative
Additional information: d3, 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 can be attributed misuse due to misaligned insertion; or prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-S-TAK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 21596925
• Report Number: 1220246-2025-00933
• Device Sequence Number: 8878076
• Product Code: MAI
• UDI-Device Identifier: 00888867097032
• UDI-Public: (01)00888867097032(11)231227(17)271130(10)15185988
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K140855
• 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): 09/08/2025

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,BIO-S-TAK
• Device Catalogue Number: AR-1934BCFT-2-1
• Device Lot Number: 15185988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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