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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 DM0210FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 03/11/2022
Event Type  Injury  
Event Description
It was reported that when using perforator to drill burr hole into skull, it cut through so quickly and cut straight through dura and the clutch mechanism did not activate.It was reported that there was dura tear of the patient but there was no intervention performed.The rest of the procedure was carried out with the help of back up device.There was no delay in procedure as a result of this event.
 
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 dm0210faa easydrill cranial perforator with 665/20 lot number was manufactured by micromar.Multiple warnings are included in the easy drill 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 easy drill 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.
 
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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
Manufacturer (Section G)
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
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 Key14210559
MDR Text Key290089651
Report Number1625507-2022-00076
Device Sequence Number1
Product Code HBF
UDI-Device Identifier07898959543180
UDI-Public07898959543180
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 Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/26/2022
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 Expiration Date05/27/2024
Device Model NumberDM0210FAA
Device Catalogue NumberDM0210FAA
Device Lot Number665/20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2022
Initial Date FDA Received04/26/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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