MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX MR8; MOTOR, DRILL, ELECTRIC

Model Number MR8

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Patient was brought from the ed (emergency department) for an emergency craniotomy for evacuation of epidural hematoma, and when the surgeon went to use the midas rex drill, the handpiece did not work.It was "set drill midas rex mr8 electric touch-008, main ortho/neuro ".Observed bent pins inside coupling.A replacement midas rex drill was immediately retrieved, opened, and used.

• Brand Name: MIDAS REX MR8
• Type of Device: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st; fort worth TX 76137
• MDR Report Key: 13839074
• MDR Text Key: 287536975
• Report Number: 13839074
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR8
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA