MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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 08/16/2024 it was reported by a sales representative via email that an ar-3652ttsp fibertak rc pulled out of the bone.The patient was not affected, and the case was not delayed.This was discovered during a procedure.
Event or Problem Description
Additional information received on 9/6/2024: this was discovered during an rotator cuff repair procedure on (b)(6) 2024.Nothing broke in the patient.The case was completed with the same ar-3652ttsp fibertak rc anchor.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6, and correction: b3.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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
• 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: 20161051
• Report Number: 1220246-2024-07440
• Device Sequence Number: 7366225
• Product Code: MBI
• UDI-Device Identifier: 10888867362946
• UDI-Public: 10888867362946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• 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
• Report Date (Section B): 06/12/2025

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 FBRTPE BLK/BLU & STTPE BLU
• Device Catalogue Number: AR-3652TTSP
• Device Lot Number: 15190729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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