MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment the complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 10/20/2022, it was reported by a sales representative via email that an ar-3633 fibertak suture anchor pulled out.Surgeon reloaded the anchor and attempted to implant it two more times, each time the anchor continued to pull out.This was discovered during an unspecified procedure on (b)(6) 2022.Case was completed by removing everything from inside the patient and opening an ar-2324pslc-2 peek swivelock.

• Brand Name: FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
• 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: emily shafer ; 8009337001
• MDR Report Key: 19350411
• Report Number: 1220246-2024-03486
• Device Sequence Number: 20619878
• Product Code: MBI
• UDI-Device Identifier: 00888867276925
• UDI-Public: 00888867276925
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• 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
• Report Date (Section B): 05/20/2024

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: FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
• Device Catalogue Number: AR-3633
• Device Lot Number: 14948300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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