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

Model Number	F2/8TA23
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pt undergoing craniotomy when drill bit broke.

• Brand Name: MIDAS REX¿
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 7772101
• Report Number: 7772101
• Device Sequence Number: 1012306
• Product Code: HBB
• UDI-Device Identifier: 00643169766259
• UDI-Public: (01)00643169766259
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/30/2018
• Report Date (Section F): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F2/8TA23
• Device Lot Number: H5436490
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/30/2018