MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH,BIO-COMP S-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 an arthrex's employee via an email that for 1 unit of ar-1934bcf-2, suture anchor, biocomposite¿ suturetak® 3 x 14.5 mm, ve5 with #2 fiberwire® and #2 tigerwire®, the end of the anchor broke during insertion.This was detected during a labral suturing surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1934bcf-2.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on photographic evidence of a fractured ar-1934bcf-2 batch 15346898.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 off-axis insertion, prying, or leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK
• 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: 23862318
• Report Number: 1220246-2025-05733
• Device Sequence Number: 15799355
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: (01)00888867023888(11)241112(17)281031(10)15346898
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/23/2026

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,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2
• Device Lot Number: 15346898
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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