MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex subsidiary employee via email that an ar-8991 fibertak dx malfunctioned.The chinese finger trap mechanism failed to function as intended during tensioning, resulting in the line loosening.The procedure was completed by using another ar-8991 fibertak dx.No significant surgical delay was reported, nothing remained in the patient, and no additional anesthesia was administered.This was discovered during an aclr procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
• 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: 23934740
• Report Number: 1220246-2025-05929
• Device Sequence Number: 14855800
• Product Code: MBI
• UDI-Device Identifier: 00888867377295
• UDI-Public: (01)00888867377295(11)250715(17)300630(10)15467222
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200341
• 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): 04/15/2026

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: DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
• Device Catalogue Number: AR-8991
• Device Lot Number: 15467222
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown