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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 1st dec 2025, 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 was pulled out when retrieving the pole.This was detected during a repair of the anterior calcaneofibular ligament 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
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-1934bcf-2 sutr anch, bio-comp s-tak batch 15378386 was received for evaluation.Visual inspection revealed that the anchor, which was still sitting at the tip of the inserter, was broken at the proximal end of the first thread.It was noted damage to the threads, most likely due to excessive force and/or misalignment during insertion.Evaluation of the sutures on the handle found no damage.A functional test was not performed due to the damage to the device.The most likely cause of the reported failure is user error, including improper bone preparation, misalignment of the insertion, and excessive force.Directions for use dfu-0054-eor7_fmt_en, 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.7.Arthrex implant specific instrumentation must be used to insert implantable devices per the recommended surgical technique.

• 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: 23862700
• Report Number: 1220246-2025-05740
• Device Sequence Number: 18466446
• Product Code: MAI
• UDI-Device Identifier: 00888867023888
• UDI-Public: (01)00888867023888(11)250127(17)281231(10)15378386
• 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,BIO-COMP S-TAK
• Device Catalogue Number: AR-1934BCF-2
• Device Lot Number: 15378386
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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