MAUDE Adverse Event Report: METRX RX SYSTEM - PITUITARY RONGEUR

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

Event Type  malfunction  

Event Description

During a surgical procedure, the surgeon was removing the instrument from the tube for cleaning, they were able to see the jaws of the instrument had broken into pieces.All the pieces were recovered and removed from the field.It was noted no harm was caused to the pt.The surgeon was performing a minimally invasive lumbar fusion using a metrx system-pituitary ronguer.Fda safety report id# (b)(4).

• Brand Name: METRX RX SYSTEM - PITUITARY RONGEUR
• Type of Device: RONGEUR
• MDR Report Key: 9245844
• MDR Text Key: 164323873
• Report Number: MW5090722
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR