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

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.

• 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 Key: 14210559
• MDR Text Key: 290089651
• Report Number: 1625507-2022-00076
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543180
• UDI-Public: 07898959543180
• 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: 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 Date: 05/27/2024
• Device Model Number: DM0210FAA
• Device Catalogue Number: DM0210FAA
• Device Lot Number: 665/20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male