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 Problem Perforation (2001)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed at this time, as the device was returned to the manufacturer for analysis.Investigation is pending manufacturer analysis.The 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.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.

Event Description

It was reported the surgeon was using the perforator to make a burr hole for a bi-lateral dbs case.While drilling on the right side of the skull, he noticed that the drill did not stop and felt a plunge into brain matter (the dura).The surgeon noticed there was slight damage to the dura but there was no cerebrospinal fluid loss due to the cut dura.The surgeon described the issue as the perforator not stopping as it should have.The surgeon proceeded to make another burr hole on the left side and used a different perforator.During the drilling of the second hole the surgeon noted it took longer than usual but the second perforator functioned without issue.The surgeon noted the skull of the patient was unusually thick; the skull measured between 2-2.5 cm at the point of perforation.The surgeon reported the skull thickness may had something to do with the device issue.It was reported there no surgical intervention due to the event.No further complications were reported as a result of this event.

Manufacturer Narrative

Report not confirmed.The device was analyzed by the manufacturer.The device passed all testing.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: cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980--390 ; 140575722
• MDR Report Key: 6877996
• MDR Text Key: 86690656
• Report Number: 1625507-2017-00032
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 133/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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