MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 21st jan 2026, it was reported by an arthrex employee via email that ar-3638 fibertak batch 15358672 encountered difficulty with the shuttle suture sliding.During the surgeon¿s attempt to lock the repair suture into the anchor, the anchor pulled out.The issue was detected intraoperatively on the same day.The user proceeded with a new anchor, and the procedure was completed successfully with no fragments retained in the patient¿s body.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FIBERTAK
• 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: 24303969
• Report Number: 1220246-2026-00493
• Device Sequence Number: 15868273
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: (01)00888867292123(11)241209(17)291130(10)15358672
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K251809
• 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): 05/28/2026

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: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 15358672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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