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

Model Number	DM0010FAA
Medical Device Problem Codes	Device Remains Activated (1525); Failure to Auto Stop (2938); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in future, product analysis may be performed continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: pss unknown, serial/lot #: unknown.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.
Event or Problem Description
It was reported that malfunction with a perforator attachment, while doing left sided burr holes for the evacuation of a hematoma.The perforator was working correctly for the first burr hole but plunged through the skull on the second burr hole, this is supposed to have a hard stop.Everything was connected correctly and the settings were not increased on the electric midas.It was reported that the patient did not seem to be injured by the perforator plunging through the skull.It was reported there was no patient impact.
Additional Manufacturer Narrative
H2: correction_ pma / 510(k)# added.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: pli 10 :evaluation could not reproduce the reported malfunction of perforator continues to run.It was noted that no abnormalities found.Pli 20: perforator attachment sn# unknown: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in future, product analysis may be performed 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: justin ellis ; 8200 coral sea street ne mvs21; av. marginal ao corrego da ser; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24231316
• Report Number: 1625507-2026-00031
• Device Sequence Number: 18446666
• Product Code: HBF
• UDI-Device Identifier: 07898959543593
• UDI-Public: (01)07898959543593(17)290703(10)1952/25
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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
• Device Lot Number: 1952/25
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided; 02/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".
• Patient Age: 69 YR
• Patient Sex: Male