MAUDE Adverse Event Report: Arthrex, Inc. SP FbrTak RC TgrTpe WH/BLK & Sttpe WH/BL; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FbrTak RC TgrTpe WH/BLK & Sttpe WH/BL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 26th august 2026, it was reported by an arthrex employee via email that for an ar-3652sp, fibertak® rc suture anchor, (white/black), the anchor dislodged upon insertion into the medial aspect of the femoral head.This was detected during use in an unknown procedure on (b)(6) 2026.The procedure was completed successfully as an alternative product (detail unknown) was opened and inserted at a different location, where it was successfully seated without issue.No significant surgery delay reported.All of the product/fragment was removed, and nothing remains in the patient.No additional anesthesia administered to the patient.No information about an instrument used to prepare/tap the bone socket for insertion of the implant.Bone quality of the patient is unknown.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SP FbrTak RC TgrTpe WH/BLK & Sttpe WH/BL
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50690421
• Report Number: 1220246-2026-04635
• Device Sequence Number: 5915621
• Product Code: MBI
• UDI-Device Identifier: 00888867362901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/09/2026

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: SP FbrTak RC TgrTpe WH/BLK & Sttpe WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 15229958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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