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	Bruise/Contusion (1754); Hematoma (1884); Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no conclusion can be drawn, as the device was not returned.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: pss.Date of event notification: 2024-apr-10.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during cranio, for tumor the tip of the drill didn't stop.It was reported that the patient suffered a significant injury and brain hematoma leading to seizure. the patient is currently in the icu but is expected to recover, with possible deficits.On follow up it was reported that the patient suffered a moderate/severe contusion, bleed and was transported to icu and remained intubated and sedated.
Additional Manufacturer Narrative
Correction: updated h2.6 from b17 to b18.Updated b5.H3: no conclusion can be drawn, as the device was discarded.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
On further information it was reported that the customer discarded the perforator and the capital devices involved in the complaint cannot be identified and not returned.

• Brand Name: EASYDRILL PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
• Manufacturer (Section D): MICROMAR INDUSTRIA E COMERCIO LTDA; cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980 -39; BR 09980-39
• Manufacturer (Section G): MICROMAR INDUSTRIA E COMERCIO LTDA; cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980 -39; BR 09980-39
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; av. marginal ao corrego da ser; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19259151
• Report Number: 1625507-2024-00144
• Device Sequence Number: 6614857
• Product Code: HBF
• UDI-Device Identifier: 07898959543586
• UDI-Public: 07898959543586
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 2257/23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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: Male