MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX; MOTOR, DRILL, PNEUMATIC

Model Number 10MH30

Device Problem Misconnection (1399)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Event Description

Bur would not click into drill.A new bur had to be opened to complete the procedure.The product did not have patient contact or patient harm.

• Brand Name: MIDAS REX
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 8793275
• MDR Text Key: 151131589
• Report Number: 8793275
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10MH30
• Device Catalogue Number: 10MH30
• Device Lot Number: 5525529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA