MAUDE Adverse Event Report: ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number 2.6 MM KNOTLESS FIBERTAK ANCHOR

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

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 Description

On 3/7/2024, it was reported by a sales representative via phone that an ar-3641 2.6 mm knotless fibertak anchor had an issue during an elbow epicondylitis procedure on (b)(6) 2024.When the surgeon tried to implant the ar-3641 2.6 mm knotless fibertak anchor, the shuttle stitch snapped, rendering the device useless.The anchor and all sutures were removed from the patient.The anchor was removed in one piece; nothing broke inside the patient.Another ar-3641 2.6 mm knotless fibertak anchor with lot number 15073677 was used to complete the procedure successfully with no harm to the patient.There was a case delay of a couple of minutes, and no additional anesthesia was administered to the patient.The complaint device was discarded, and no pictures were taken.This occurred during use with no patient harm.

• Brand Name: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Type of Device: 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: 18960564
• MDR Text Key: 338466684
• Report Number: 1220246-2024-01643
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867287457
• UDI-Public: 00888867287457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641
• Device Lot Number: 15158792
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1