MAUDE Adverse Event Report: MEDTRONIC NAVIGATION INC. MIDAS REX DRILL; MOTOR, DRILL, PNEUMATIC

Model Number F 1/8 TA15

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Craniotome tip broke on the patient's skull while performing procedure.Fda safety report id# (b)(4).

• Brand Name: MIDAS REX DRILL
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION INC.
• MDR Report Key: 11404134
• MDR Text Key: 234666177
• Report Number: MW5099732
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2021

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: F 1/8 TA15
• Device Catalogue Number: F1-B5 8-B
• Device Lot Number: 0221105393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• 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): Other
• Patient Age: 4 YR
• Patient Weight: 16