MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2024
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 12/9/2024, it was reported by a sales representative via email that the eyelets of three ar-2923bc biocomposite pushlock eyelets broke off while barely inserting the anchor into the bone.Everything was removed from the patient.The case was completed using 1.8 knotless fibertak devices.This was discovered during a procedure on (b)(6) 2024.Additional information requested 12/16/2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 12/18/2024: this was discovered during a labral repair procedure.The anchors were removed from the patient.The case was completed using an ar-3636 knotless fibertak.The case was delayed twenty minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• 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: 21080329
• Report Number: 1220246-2025-09224
• Device Sequence Number: 12845425
• Product Code: MAI
• UDI-Device Identifier: 00888867099203
• UDI-Public: (01)00888867099203(11)230516(17)250430(10)15093345
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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 Expiration Date: 04/30/2025
• Device Model Number: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 15093345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 06/16/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/14/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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