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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
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 11/17/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1934bcf-2 biocomposite¿ suturetak anchor was damaged during insertion.The base of the sutures broke, making it unusable.This was discovered during a biceps lesion procedure with no patient harm.The case was completed with another device.Additional information provided on 11/26/2025: it was further reported that the hole for the anchor was made using a suturetak anchor drill and the doctor used the material correctly, the patient's bone was very hard, which caused the anchor to break, not the drill.There were no loose fragments reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of a damaged ar-1934bcf-2, batch 15364204.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 user-related, such as misaligned insertion, improper bone preparation, or prying or leveraging the device.

• 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: 23742056
• Report Number: 1220246-2025-05459
• Device Sequence Number: 21448777
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: (01)00888867023888(11)241219(17)281130(10)15364204
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/10/2026

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: 15364204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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