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

Model Number DM0010FAA

Device Problem Device Remains Activated (1525)

Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895); Perforation (2001)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Report inconclusive.The perforator has not been returned.If the device is returned, it will be forwarded to the manufacturer for evaluation.The device history records were reviewed by the manufacturer and all specifications were met prior to release.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 monitor this complaint type for trends.

Event Description

It was reported by the sales representative that the easy drill perforator plunged into a patient¿s brain during a dbs procedure.There was a surgeon attending, however, a resident was using the perforator.It was alleged by the resident the perforator ¿drew him in¿, and tore through the dura and into the brain which caused bleeding.The resident also reported the skull thickness was normal and it was measured at 2cm thick.It was reported the patient was being watched, but the status was not known.On follow up it was reported the event occurred on the first perforation.It was also reported that a homeostasis agent was used to reduce the bleeding at the time of the incident.On follow the patient status was not provided by the facility.Additional patient identifier information was obtained.The concomitant device model numbers were provided without serial numbers.It was reported the perforator was not returning, and was being held in risk management at the facility.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A voluntary medsun report ((b)(4)) was received with the following event description: while the surgeon was using the perforator to complete a burr hole (placement of deep brain stimulating leads), it failed to auto stop and plunged through the dura and penetrated the brain tissue.The patient had a right frontal intraparenchymal hemorrhage (ipg).She was transferred to (b)(6) rehab.She continued to rehabilitate and was discharged home with family weeks later.The device was sequestered.On follow up with the hospital it was reported the device would not be returned for analysis.

Manufacturer Narrative

Report not confirmed.Evaluation could not reproduce the reported malfunction of continues to run.This dm0010faa easydrill cranial perforator with lot number 274/17 was manufactured by micromar.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.

• 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 -390; BR 09980-390
• MDR Report Key: 6916816
• MDR Text Key: 88381309
• Report Number: 1625507-2017-00033
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (y/n): N
• PMA/PMN Number: K141455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2019
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 274/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AD03 ATTACHMENT, S/N UNK, EM200 MOTOR, S/N UNK
• Patient Outcome(s): Other
• Patient Age: 67 YR