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); Perforation (2001)

Event Date 11/21/2017

Event Type  Injury  

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 dm0010faa perforator with lot number 702/16 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 monitor this complaint type for trends.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the perforator continued to run and did not stop like it was supposed to.Thus, the patient suffered a dura and cortex lesion with some hemorrhage subsequent due to the perforator not stopping.On follow up it was reported the cortical bleeding was immediately treated.The cortical bleeding was reduced with bipolar coagulation and hemostatic (surgiflo+surgicell).The subcortical bleeding did not require surgical evacuation, but the patient was submitted to serial brain cts to assure stability and resolution.The event occurred during the first burr hole while physician was performing a dbs procedure.The burr hole site was in the pre-coronal region.The skull was described as usually fairly thick.More than 5 mm.The current status of the patient was described as well and healthy.Patient identification information was provided.Information on the concomitant devices was also provided.

Manufacturer Narrative

Report not confirmed.Evaluation could not reproduce the reported malfunction of continues to run.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 and did not reflect any conditions related to the current, reported malfunction.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
• Manufacturer (Section G): 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
• Manufacturer Contact: natalia matos ; cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980--390 ; BR 09980-390 ; 77886587
• MDR Report Key: 7127608
• MDR Text Key: 95173581
• Report Number: 1625507-2017-00042
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2018
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 702/16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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 Age: 66 YR