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

Model Number	DM0010FAA
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inclusive.No evaluation was performed as the device was not returned.This dm0010faa perforator with lot number 101/17 was m anufactured 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.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.Physicians:(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that surgeon was experiencing that the cranial perforator easy drill did not stop and damaged the dura.On follow up it was confirmed this occured back in (b)(6) 2018 and was not reported to the device manufacturer.It was also noted that this may have occurred with two different surgeons at this hospital but this has not been confirmed.It was reported that the current condition of the patient is stable.
Additional Manufacturer Narrative
The device has been returned and is still pending their evaluation results.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction of continues to run.If information is provided in the future, a supplemental report will be issued.

• 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: 7857510
• Report Number: 1625507-2018-00050
• Device Sequence Number: 1950491
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2019
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 107/17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 10/25/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/15/2018; 10/25/2018
• 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