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

Model Number	DM0011FAA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a ventriculoperitoneal shunt procedure, while using the midas disposable cranial perforator, the surgeon alleged that the perforator caused damage to the brain.The event occurred during drilling.It was also noted that the perforator was used with the motor and attachment combination (motor and attachment).There was an associated procedure delay of approximately one to two hours.Additional information was received stating that the patient was reported to be in good condition after the operation, and no fragments remained inside the patient.The user indicated that the perforator penetrated the bone but did not stop.The malfunction occurred on the first hole.Additional information was received stating that the customer confirmed no additional malfunctions were identified with the perforator, motor, or attachment.It was reported there was no patient impact, and the patient is recovering without complications.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: em800, serial/lot #: (b)(6), udi#: (b)(4); product id: mr8-ad03, serial/lot #: (b)(6), udi#: (b)(4).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 easydrill worked as expected and had no malfunctions.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 ; cnpj: 53.168.142/0001-29; av. marginal ao corrego da s; sao paulo,sp 09980--39 ; BR 09980-39 ; 22713209
• MDR Report Key: 23702208
• Report Number: 1625507-2025-02361
• Device Sequence Number: 10628667
• Product Code: HBF
• UDI-Device Identifier: 07898959543616
• UDI-Public: (01)07898959543616(17)281219(10)3494/24
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DM0011FAA
• Device Catalogue Number: DM0011FAA
• Device Lot Number: 3494/24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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