MAUDE Adverse Event Report: ARTHREX, INC. DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
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 1027/2025, it was reported by a sales representative via email that an ar-8990st-2 fibertak dx anchor bent immediately on insertion.This was discovered during a brostrom procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 10/31/2025: the anchor was removed from the patient, and all fragments were retrieved.The case was completed using ar-8934bcst 3.0 single-loaded suture tape s-tak assy.There was no case delay or added anesthesia administered to the patient.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking and/or being damaged.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.

• Brand Name: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• 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: 23466928
• Report Number: 1220246-2025-04996
• Device Sequence Number: 21052684
• Product Code: MBI
• UDI-Device Identifier: 00888867377370
• UDI-Public: (01)00888867377370(11)230413(17)280331(10)15080220
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• 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): 03/09/2026

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: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Device Catalogue Number: AR-8990ST-2
• Device Lot Number: 15080220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided; 03/03/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/07/2025; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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