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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 6/13/2024 it was reported by a sales representative via phone that an ar-3652sp fibertak rc suture anchor had an issue during a rotator cuff procedure on (b)(6) 2024.After the insertion of the complaint device into the patient, when a camera was brought in, it looked like the fork tip in the middle had almost pierced through the suture anchor.The suture anchor was still on the inserter at that point, and everything was removed from the patient in one piece.Nothing broke inside the patient.Another ar-3652sp fibertak rc suture anchor with the same lot number was used to successfully complete the procedure with no harm to the patient.The new suture anchor was checked before insertion into the patient and was fully functional.A 5-minute case delay was reported but no additional anesthesia was administered.The complaint device was discarded and no pictures were taken.This occurred during use with no reported patient harm.
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 of the device due to misaligned insertion and/or prying/leveraging during insertion.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19688675
• Report Number: 1220246-2024-06612
• Device Sequence Number: 7081074
• Product Code: MBI
• UDI-Device Identifier: 10888867362908
• UDI-Public: 10888867362908
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 TGRTPE WH/BLK & STTPE WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 15116538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown