MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER CORE 2 NEUROLOGICAL DRILL HLTHCR SYSTEM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407-120-970C

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2023

Event Type  Injury  

Event Description

While surgeon was using the neuro electric hand drill, he noticed that the attachment to the drill was hot to the touch.When passed back to the scrub person, the drill was noted to have charring on the end of the attachment and on the burr.A new drill, attachment, and burr were added to the sterile field and used for the rest of the procedure.

• Brand Name: STRYKER CORE 2 NEUROLOGICAL DRILL HLTHCR SYSTEM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; kalamazoo MI
• MDR Report Key: 16436752
• MDR Text Key: 310271737
• Report Number: MW5115148
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5407-120-970C
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention