MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number MR8-F2/7TA23

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2023

Event Type  Injury  

Event Description

During a craniotomy and tumor resection the drill bit broke off during the removal of a bone flap.Two pieces were found and imaging shows a foreign body believed to be add'l piece of the drill bit.

• Brand Name: DRILL BIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; fort worth TX 76137
• MDR Report Key: 17282079
• MDR Text Key: 318656785
• Report Number: MW5119198
• Device Sequence Number: 1
• Product Code: NLN
• Combination Product (y/n): N
• 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: 06/30/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MR8-F2/7TA23
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White