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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2026
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 dec 2025, it was reported by an arthrex employee via email that for ar-1322bcnf lot/serial no 15394127 sutures pulled out of anchor during use.This was detected during use a right acetabulum surgical fixation kiv right greater trochanter osteotomy; left ankle relooks debridement kiv conversion to circular fixation procedure on (b)(6) 2025.The procedure was completed successfully with another anchor, and no piece break off inside patient.

• 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: 24180932
• Report Number: 1220246-2026-00328
• Device Sequence Number: 9486545
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: (01)00888867010147(11)250224(17)290131(10)15394127
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/26/2026

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: 15394127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown