MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS EASYDRILL CARANIAL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number DM0010FAA

Device Problem Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/10/2023

Event Type  malfunction  

Event Description

During craniotomy procedure using the perforator which is designed to have a depth guard to limit how deep it drills failed and the bit came in contact with tissue.Luckily, no harm to patient.Physician was able to control bleeding with gelfoam which was later removed.The medtronic rep was in the or and wrote down device information to share with medtronic.We have removed all perforators with this lot number and will be working with the medtronic team.I have the device and would like to get it sent back to manufacturer for their input.

• Brand Name: EASYDRILL CARANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 16794975
• MDR Text Key: 313831654
• Report Number: 16794975
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 2625/22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White