MAUDE Adverse Event Report: CNPJ: 53.168.142/0001-29 EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU

Model Number	DM0011FAA
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the corpus callosotomy the perforator burr failed to stop once inner most bi cortical layer of the cranium due to which dura was damaged.It was reported that the producer got delayed for 30 minutes to 1 hour and the procedure was completed with the reported product.
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.This dm0011faa easydrill cranial perforator with 0738/22 lot number was manufactured by micromar.Multiple warnings are included in the easydrill cranial perforator ifu manual including: it is essential to keep the drill perpendicular (90°) at the predetermined point of the skull to be drilled, as an excessive deviation from perpendicularity may cause the product to fail and lead to serious patient injury.Select a drill bit suitable for the bone thickness.This prevents the drill from tearing the bone or brain tissue (similar effect when the bit is not positioned at 90°).If the components of the easydrill cranial perforator become loose during trephination, discontinue use.The drill can cut or tear the dura mater when it unlocks.Check some conditions before performing the procedure, such as the existence of adhering dura mater or other anomalies adjacent to the drilling site.We will continue to track and trend this complaint type.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 could not reproduce the reported malfunction of continues to run.It was also noted that the visual and performance tests were carried out, and no non-conformities were found.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
On additional follow up it was reported that the patient is stable after operation.

• Brand Name: EASYDRILL PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
• Manufacturer (Section D): CNPJ: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo; sp,br 09980 -39; BR 09980-39
• Manufacturer (Section G): CNPJ: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo; sp,br 09980 -39; BR 09980-39
• Manufacturer Contact: natalia matos ; cnpj: 53.168.142/0001-29; av. marginal ao corrego da se; sao paulo,sp 09980--39 ; BR 09980-39 ; 140575722
• MDR Report Key: 19141374
• Report Number: 1625507-2024-00126
• Device Sequence Number: 18003026
• Product Code: HBF
• UDI-Device Identifier: 07898959543173
• UDI-Public: 07898959543173
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/18/2024

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 Expiration Date: 04/08/2026
• Device Model Number: DM0011FAA
• Device Catalogue Number: DM0011FAA
• Device Lot Number: 0738/22
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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 Age: 24 MO
• Patient Sex: Male