MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-S-TAK,SM JNT; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,BIO-S-TAK,SM JNT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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 11th feb 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-8934bnf, small joint bio-suturetak® with needles, 3.0 mm, with 2x #0 fiberwire®, its anchor broke during insertion.This was detected during a mbo procedure on (b)(6) 2026.The procedure was completed successfully by using a replacement device (ar-8934bnf).There was no patient harm.

• Brand Name: SUTR ANCH,BIO-S-TAK,SM JNT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 24482978
• Report Number: 1220246-2026-01123
• Device Sequence Number: 12016177
• Product Code: HWC
• UDI-Device Identifier: 00888867050372
• UDI-Public: (01)00888867050372(11)250815(17)290731(10)15483316
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050749
• 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): 06/15/2026

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: SUTR ANCH,BIO-S-TAK,SM JNT
• Device Catalogue Number: AR-8934BNF
• Device Lot Number: 15483316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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