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

Model Number	DM0008FAA
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.This easydrill cranial perforator was manufactured by micromar.The device history records were reviewed by micromar 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the perforator did not stop and caused the dura to become broken.It was reported that there was no other patient impact.On follow up it was reported by the surgeon that the perforator did not stop.When he saw this, he withdrew the drill and there was no injury to the patient.The current status of the patient was described as ¿ok¿.There was no further information provided regarding the patient.The event occurred on the first trepanation.The surgeon indicated the initial tests were performed prior to first use.This was the initial use of the perforator.The concomitant device description was provided without the serial number and the surgeon¿s full name was provided.

• Brand Name: EASYDRILL PERFORATOR
• Common Device Name: 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: 6982874
• Report Number: 1625507-2017-00037
• Device Sequence Number: 488231
• Product Code: HBF
• UDI-Device Identifier: 07898959543050
• UDI-Public: 07898959543050
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2019
• Device Model Number: DM0008FAA
• Device Catalogue Number: DM0008FAA
• Device Lot Number: 224/17
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EM200 MOTOR, S/N UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR