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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 10/24/2024, it was reported by a sales representative via email that an ar-3652ttsp fibertak rc inserter bent while it was malleted into the bone.The anchor did not make it into the bone and was unable to be used due to the inserted bending.This was discovered during a procedure on (b)(6) 2024.Additional information received on 10/30/2024: this was discovered during an rcr procedure.The case was completed using another ar-3652ttsp fibertak rc.The case was delayed approximately one to two minutes.Enough anesthesia was administered for those extra minutes.
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 misuse due to applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.

• 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: 20620555
• Report Number: 1220246-2024-08434
• Device Sequence Number: 7353367
• Product Code: MBI
• UDI-Device Identifier: 00888867362949
• UDI-Public: (01)00888867362949(11)240510(17)290430(10)15246499
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/28/2025

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: 15246499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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