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

Model Number F3/9TA30

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Intraoperative patient was having craniotomy for tumor resection, during removal of bone flap, the skull was extremely thick and s1 drill bit broke and was unaccounted for.At approx.1800, i found the broken piece on the floor verified all pieces were found and they were placed in the case cart for next nurse coming on shift.

• 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: 11869526
• MDR Text Key: 252166160
• Report Number: 11869526
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F3/9TA30
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA