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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 13548421
• Device Sequence Number: 14749214
• Product Code: HBF
• UDI-Device Identifier: 07898959543333
• UDI-Public: (01)07898959543333
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2022
• Report Date (Section F): 02/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 113 KG
• Date Report Sent to FDA: 02/07/2022