MAUDE Adverse Event Report: MEDTRONIC EASYDRILL CRANIAL PERFORATOR; PERFORATOR

Catalog Number DM0010FAA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

Cranial perforator broke off inside of patient's skull while burr hole was being drilled.Surgeon had to manually remove perforator bit from skull.

• Brand Name: EASYDRILL CRANIAL PERFORATOR
• Type of Device: PERFORATOR
• Manufacturer (Section D): MEDTRONIC ; fort worth TX
• MDR Report Key: 11626970
• MDR Text Key: 244419869
• Report Number: 11626970
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 1462/19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Distributor Facility Aware Date: 02/19/2021
• Event Location: Hospital
• 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 Age: 77 YR