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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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 10/09/2025, a sales representative reported via email that an ar-8991 fibertak dx suture anchor pulled out of the bone while the surgeon passed the repair suture through the tendon.Initially, a 1.8 mm drill was used, but they switched to a 1.6 mm drill and used another anchor, which functioned as intended.The original anchor could not be reloaded because the inserter broke, requiring a second ar-8991 fibertak dx suture anchor.This issue was identified during a procedure on (b)(6) 2025.Additional information has been requested on 10/10/2025.
Event or Problem Description
Additional information was received on 10/15/2025: this issue occurred during a tendon repair procedure on 10/09/2025.The case was delayed seven minutes.It is unknown if additional anesthesia was administered.No adverse effects were reported during or following the surgery.Additional information was requested on 10/21/2025: the anchor that pulled out from the first ar-8991 fibertak dx suture anchor was on the inserter that broke.The second ar-8991 did not fail and functioned as intended.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 10/15/2025: this issue occurred during a tendon repair procedure on (b)(6) 2025.The case was delayed seven minutes.It is unknown if additional anesthesia was administered.No adverse effects were reported during or following the surgery.Additional information has been requested on 10/17/2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 user error due to misaligned insertion and/or improper bone preparation.

• 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: 23316711
• Report Number: 1220246-2025-04661
• Device Sequence Number: 5815094
• Product Code: MBI
• UDI-Device Identifier: 00888867377295
• UDI-Public: (01)00888867377295(11)250619(17)300531(10)15453882
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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,Followup
• Report Date (Section B): 02/02/2026

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: 15453882
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/29/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/22/2025; 10/30/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown