MAUDE Adverse Event Report: Arthrex, Inc. BIO-COMP S-TAK 2.4X 12MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP S-TAK 2.4X 12MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 1st september 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-1934bcf-24-2, 2.4 mm biocomposite suturetak® suture anchor with one #2 fiberwire® and one #2 tigerwire®, its anchor pulled out during insertion.This was detected during a labial 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.

• Brand Name: BIO-COMP S-TAK 2.4X 12MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50772857
• Report Number: 1220246-2026-04726
• Device Sequence Number: 10615014
• Product Code: MAI
• UDI-Device Identifier: 00888867023918
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K252314
• 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
• Report Date (Section B): 09/15/2026

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: BIO-COMP S-TAK 2.4X 12MM
• Device Catalogue Number: AR-1934BCF-24-2
• Device Lot Number: 15274609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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