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

Model Number DM0011FAA

Device Problem Device Remains Activated (1525)

Patient Problem Perforation (2001)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a craniotomy/tumor resection case, the surgeon was drilling 3 holes using the perforator.The first 2 holes went fine, however while drilling the third hole it was reported that instrument seemed to plunge forward and ended up hitting the dura of the patient.No significant patient harm was reported.On follow up it was reported that there was no additional action taken to prevent impact or injury and there was no delay in procedure as a result of this event.

Manufacturer Narrative

Correction: updated d9, h3, h6 (imdrf c and d codes), h7 and h10 as the device returned for evaluation.Summary correction (h10): no conclusion can be drawn.Device was returned and the evaluation anticipated but not yet begun.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EASYDRILL PERFORATOR
• Type of Device: 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 ser; sao paulo,sp 09980--39 ; BR 09980-39 ; 140575722
• MDR Report Key: 15723077
• MDR Text Key: 303035112
• Report Number: 1625507-2022-00246
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543173
• UDI-Public: 07898959543173
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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
• Device Operator: Health Professional
• Device Model Number: DM0011FAA
• Device Catalogue Number: DM0011FAA
• Device Lot Number: 1083/20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other