MAUDE Adverse Event Report: ARTHREX, INC. SS OPEN CNULA,TPR DETACHABLE HNDL; ARTHROSCOPIC ACCESSORIES

Model Number SS OPEN CNULA,TPR DETACHABLE HNDL

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

It was reported during a hip scope procedure the surgeon was using the ar-6507-03 and ar-6507-04 to get into joint, and both devices bent.

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.Complaint confirmed, the device was found to be severely bent.A likely cause of the event is user-applied mechanical forces.

• Brand Name: SS OPEN CNULA,TPR DETACHABLE HNDL
• Type of Device: ARTHROSCOPIC ACCESSORIES
• 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: 19082169
• MDR Text Key: 340687638
• Report Number: 1220246-2024-01962
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867039575
• UDI-Public: 00888867039575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/10/2024

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: SS OPEN CNULA,TPR DETACHABLE HNDL
• Device Catalogue Number: AR-6507-03
• Device Lot Number: 0071709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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