MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-3602-2 fibertak shaft broke while being inserted through the curved guide.All the broken fragments were retrieved, and the case was completed using a new product.This was discovered during a meniscus repair procedure on (b)(6) 2023.Additional information received on (b)(6) 2023: the shaft broken fragments were contained within the curved guide and were not loose in the patient.
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 causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• 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: 17377512
• Report Number: 1220246-2023-07266
• Device Sequence Number: 6506467
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 DOUBLE LOADED W/ 1.3 SUTURETAPE
• Device Catalogue Number: AR-3602-2
• Device Lot Number: 14938681
• 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: 11/05/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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