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	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th march 2026, 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®, its anchor broke during insertion.This was detected during an ankle joint instability 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
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.The complaint allegation is confirmed.One unpackaged ar-1934bcf-2, serial/batch number (b)(6), was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the anchor of the device is broken, with half of the anchor remaining in the device, while the other half is broken.Per the dfu (directions for use) bio-fastak, fastak¿, suturetak® and fibertak® suture anchors, dfu-0054-eo revision 8, e.Warnings 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.8.Visually inspect all devices immediately after use for the potential of loose body remnants left behind in the patient.9.Suturetak and fibertak suture anchors only: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Increased size, hard bone drills are also available for use.The most likely cause is attributed to misuse/use error due to excessive force/misaligned insertion and/or improper bone prep, which caused the anchor of the device to become chipped/broken.

• 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: 24715232
• Report Number: 1220246-2026-01715
• Device Sequence Number: 20253259
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: (01)00888867023888(11)231114(17)271031(10)15167542
• 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): 05/05/2026

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: 15167542
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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