MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CUTTER; MANUAL INSTR, GENERAL SURGICAL

Model Number FIBERTAPE CUTTER

Device Problem Break (1069)

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

Event Date 02/12/2021

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff repair, the ar-13250 wasn't performing correctly during surgery and the surgeon broke the device.The case was completed by using a new ar-13250 without further issue.

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 related condition is typically caused by applying leveraging forces.Unable to perform function test due to the related condition.

• Brand Name: FIBERTAPE CUTTER
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 19138273
• MDR Text Key: 340685993
• Report Number: 1220246-2024-02137
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867010413
• UDI-Public: 00888867010413
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Model Number: FIBERTAPE CUTTER
• Device Catalogue Number: AR-13250
• Device Lot Number: 47538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1