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

Model Number MC30

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  Injury  

Event Description

Midas rex metal cutting burr broke into multiple pieces while in use.All pieces were retrieved.Surgery progressed as planned.No delay occurred.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC MIDAS REX METAL CUTTING BURR
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS
• MDR Report Key: 12664998
• MDR Text Key: 277769165
• Report Number: MW5104766
• Device Sequence Number: 1
• Product Code: HBB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2021

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: MC30
• Device Catalogue Number: MC30
• Device Lot Number: 0222520622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 81