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

Model Number	DM0010FAA
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Contusion (1787); Hemorrhage/Blood Loss/Bleeding (1888); Paresis (1998)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.The device has been returned and is still pending their evaluation results.This dm0010faa easydrill cranial perforator with lot number 248/17 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 or Problem Description
It was reported that a burr hole was made and the perforator did not stop tearing the dura-mater and brain in the rolandic area.Patient is alive with injury.According to physician, patient had slight paresis and contusion focusing on rolandic (motor) area.On follow up, it was reported and confirmed with hcp that there was a 40 minute delay to stop the bleeding and re-establish the surgical field in order to continue the surgery.Surgery was continued and biopsy was done.Patient recovered, as expected, and has already left the hospital.
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction of continues to run.No other anomalies were identified.This dm0010faa easydrill cranial perforator with lot number 248/17 was manufactured by micromar.Device history record was reviewed by micromar and per their report, all the processes were executed according to what was planned and validated.There were no observations or nonconformities during the manufacturing process was reviewed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EASYDRILL PERFORATOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, 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: 7946779
• Report Number: 1625507-2018-00057
• Device Sequence Number: 2255349
• Product Code: HBE
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 11/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2019
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 248/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR