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U.S. Department of Health and Human Services

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

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MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU Back to Search Results
Model Number DM0010FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that the perforator that kept spinning and going through the bound.It was reported that there was no patient impact.Additional information regarding the product return was being followed up.
 
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 dm0010faa easydrill cranial perforator with lot number 0734/22 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 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.
 
Manufacturer Narrative
No evaluation was performed, as the device was discarded.Date of event corrected from 21-jun-2022 to 20-jun-2022.Additional codes imf corrected from f24 to f26.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.
 
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Brand Name
EASYDRILL PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
Manufacturer (Section D)
MICROMAR INDUSTRIA E COMERCIO LTDA
cnpj: 53.168.142/0001-29
av. marginal ao corrego da s
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 s
sao paulo,sp 09980 -39
BR   09980-39
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 Key15207486
MDR Text Key303039457
Report Number1625507-2022-00177
Device Sequence Number1
Product Code HBF
UDI-Device Identifier07898959543197
UDI-Public07898959543197
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/13/2022
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
Device Operator Health Professional
Device Model NumberDM0010FAA
Device Catalogue NumberDM0010FAA
Device Lot Number0734/22
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/21/2022
Initial Date FDA Received08/11/2022
Supplement Dates Manufacturer Received11/15/2022
Supplement Dates FDA Received12/13/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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