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

Model Number T12MH45D

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Event Description

Drill bit broke in half while in use with electric drill.Drill bit replaced and pieces retrieved.Procedure under fluoro, surgeon confident the pieces were retrieved.

• 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: 11169670
• MDR Text Key: 226783936
• Report Number: 11169670
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T12MH45D
• Device Lot Number: H5566109
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA