MAUDE Adverse Event Report: MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU

Model Number	DM0010FAA
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Hematoma (1884); Perforation (2001)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received by medtronic indicated that the perforator bit didn't stop in surgery as it should be.It was also reported that the patient had a little hematoma, but in the end everything went fine and no problems after.Additional information was received stating that the patient underwent a brain biopsy through a borehole.A medtronic disposable drill bit was used, which should stop automatically after going through the skull and losing resistance.However, this did not happen, and the drill continued to rotate, also drilling the cortex and causing damage/leakage to the outermost layer of the patient's brain.The patient woke up from the procedure without any problems and underwent ct scans, which showed a small hematoma in the patient.The product information was written down, and the representative of the product will be informed about this.On follow up it was reported that the there were no intervention performed, no product damage and no procedure delay, the procedure completed normally.
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn.Device was returned and the evaluation anticipated but not yet begun.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis :evaluation determined that the customer allegation of perforator bit didn't stop was not confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EASYDRILL PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
• Manufacturer (Section D): MICROMAR INDUSTRIA E COMERCIO LTDA; cpnj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980 -390; BR 09980-390
• Manufacturer (Section G): MICROMAR INDUSTRIA E COMERCIO LTDA; cpnj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980 -390; BR 09980-390
• Manufacturer Contact: natalia matos matos ; cpnj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980--390 ; BR 09980-390 ; 22713209
• MDR Report Key: 23508236
• Report Number: 1625507-2025-02284
• Device Sequence Number: 13021178
• Product Code: HBF
• UDI-Device Identifier: 07898959543593
• UDI-Public: (01)07898959543593(17)290213(10)0425/25
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K141455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 0425/25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown