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

Model Number DM0010FAA

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed, as the device was destroyed by the customer.No conclusion can be drawn for the em100-a and ad03, as these devices were not returned.If these devices were returned in the future, product analysis may be performed.This dm0010faa easydrill cranial perforator with lot number 193/19 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 craniotomy procedure, the perforator stopped, however, the torque was transmitted to the attachment including the motor and rotates in the surgeon's hand.It was also reported that there was no delay on the procedure and it was completed using the reported device.On follow up, it was reported that the patient bleed for minutes but it was controlled by the surgeon.On further follow up, no additional information can be provided regarding the status of the patient and the perforator will not be returned as it has been destroyed by the customer.They also added that an em100-a and an ado3 was used during this event, however, there was no further information regarding the serial numbers.

• Brand Name: EASYDRILL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• 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: 10936794
• MDR Text Key: 219327868
• Report Number: 1625507-2020-00226
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 193/19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EM100-A (S/N: UNKNOWN), AD03 (S/N: UNKNOWN)
• Patient Outcome(s): Other