MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MINI BC S-TAK 2.4X 8.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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 4th dec 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1322bcnf, suture anchor, mini biocomposite suturetak® 2.4 x 8.5 mm with 2-0 fiberwire® with two taper point needles, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1322bcnf.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1322bcnf suture anchor, mini biocomposite suturetak® 2.4 x 8.5 mm with 2-0 fiberwire® with two taper point needles, batch number 15325085, was received for evaluation.Visual inspection found that the anchor was broken; the resulting pieces were not received for evaluation.The remaining threads were damaged.It was observed that the sutures and needles are still assembled on the handle.A functional test was not performed because the device was damaged.The most likely cause(s) of the reported failure are user error, improper bone preparation, misaligned insertion, or excessive forces applied by leveraging/prying the device.Directions for use (b)(4) at revision 7 bio-fastak, fastak¿, suturetak®, and fibertak® suture anchors.G.Precautions.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.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.

• Brand Name: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• 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: 23888096
• Report Number: 1220246-2025-05801
• Device Sequence Number: 9464019
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: (01)00888867010147(11)241001(17)280930(10)15325085
• 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): 03/10/2026

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 MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Device Lot Number: 15325085
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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