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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 27th jan 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 a glenoid labrum injury repair surgery on (b)(6) 2026.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 was confirmed.One unpackaged ar-1934bcf-2, suture anchor, biocomposite suturetak® 3 x 14.5 mm, ve5 with #2 fiberwi re® and #2 tigerwire, batch 15327840, was received for evaluation.Visual inspection confirmed that the anchor was not returned for evaluation.It was noted that the suture, previously assembled with the anchor, was lodged inside the inserter shaft.No damage was observed on the suture tails or handle.A functional test was not performed because the device was damaged.The most likely cause of the reported failure is use error, which includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.Directions for use dfu-0054-eo at revision 8- 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,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: 24331568
• Report Number: 1220246-2026-00566
• Device Sequence Number: 4811047
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: (01)00888867023888(11)241007(17)280930(10)15327840
• 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): 05/06/2026

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: 15327840
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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