MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th march 2025, it was reported by an arthrex employee via email that for an ar-1320bcnf, suture anchor, micro biocomposite suturetak® 2.4 x 6.5 mm with 2-0 fiber wire® with two taper point needles's anchor broke off during insertion.This was discovered during a repairing of anterior talofibular ligament injury of ankle joint surgery on (b)(6) 2025.The case was completed successfully by using a new ar-1320bcnf.There was no patient harm and no secondary procedures needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1320bcnf, batch 15251834, was received for investigation.- visual evaluation noted that the needle and anchor were received for investigation.Both components had damage along them.- functional testing was not performed due to damage to the device.The most likely cause of the reported failure is misaligned insertion, which involves prying/leveraging the device during insertion.- the complaint allegation is confirmed.- refer to investigation photos.

• Brand Name: SUTR ANCH MICROBIO-COMP S-TAK 2.4X 6.5MM
• 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: 21650858
• Report Number: 1220246-2025-01039
• Device Sequence Number: 18453034
• Product Code: MAI
• UDI-Device Identifier: 00888867009813
• UDI-Public: (01)00888867009813(11)240521(17)280430(10)15251834
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 MICROBIO-COMP S-TAK 2.4X 6.5MM
• Device Catalogue Number: AR-1320BCNF
• Device Lot Number: 15251834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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