MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/27/2023, it was reported by a sales representative via email that an ar-3652sp fibertak rc anchor tip bend upon insertion.The case was completed using a swivelock.This was discovered during an rcr procedure on (b)(6) 2023.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on the image provided from the field.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to use error of the device due to excessive force used to pry and/or leverage the device.

• Brand Name: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17378784
• Report Number: 1220246-2023-07272
• Device Sequence Number: 12244570
• Product Code: MBI
• UDI-Device Identifier: 10888867362908
• UDI-Public: 10888867362908
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K203268
• 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): 02/12/2025

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 TGRTPE WH/BLK & STTPE WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 14978969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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