MAUDE Adverse Event Report: MICROMAR INDÚSTRIA E COMÉRCIO LTDA EASYDRILL CRANIAL PERFORATOR Ø14 X Ø11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

Device Problem Failure to Shut Off (2939)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

While creating the second burr hole in the skull, the perforator did not automatically stop once it made it through the skull.

• Brand Name: EASYDRILL CRANIAL PERFORATOR Ø14 X Ø11 X 3MM
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDÚSTRIA E COMÉRCIO LTDA; 12343 nw 25th st; coral springs FL 33065
• MDR Report Key: 13548421
• MDR Text Key: 285757758
• Report Number: 13548421
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543333
• UDI-Public: (01)07898959543333
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Male
• Patient Weight: 113 KG