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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 DM0011FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 05/19/2021
Event Type  Injury  
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 735/20 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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a shunt placement case, the perforator plunged into the brain and pushed some bone inside but was retrieved.
 
Event Description
On follow-up, it was reported that there was a minimal procedure delay of 2 to 5 minutes to work on the burr holes and the procedure was completed using the reported device.It was also reported that there was no additional actions taken because of the event and the patient had no further issues post-surgery.
 
Manufacturer Narrative
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 ser
sao paulo,sp 09980 -39
BR  09980-39
MDR Report Key11980067
MDR Text Key263433534
Report Number1625507-2021-00135
Device Sequence Number1
Product Code HBF
UDI-Device Identifier07898959543173
UDI-Public07898959543173
Combination Product (y/n)N
PMA/PMN Number
K141455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/21/2021
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 Expiration Date06/10/2024
Device Model NumberDM0011FAA
Device Catalogue NumberDM0011FAA
Device Lot Number735/20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/19/2021
Initial Date FDA Received06/10/2021
Supplement Dates Manufacturer Received08/30/2021
Supplement Dates FDA Received09/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
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