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 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Report inconclusive.The perforator has not been returned.If the device is returned, it will be forwarded to the manufacturer for evaluation.The device history records could not be reviewed by the manufacturer due to the lot number being unknown.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 that the easy drill perforator did not stop, causing a laceration to the dura.The ipc console was set at 60,000 rpm, but the surgeon indicated it never exceeded 30,000.It was reported there were no patient symptoms or complications associated with the event.On follow up it was confirmed the patient is doing fine without damage connected to the incident.The patient¿s injury did not have to be treated, nor does the patient require follow up.Patient identifier information was not provided.It was also reported the perforator was discarded.The first trepanation hole was completed without incident.The event occurred on the second trepanation.The surgeon completed an uneventful third trepanation.Concomitant models were provided; however, the serial numbers were unknown.

• 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 ; 140575722
• MDR Report Key: 6964498
• MDR Text Key: 89809794
• Report Number: 1625507-2017-00036
• Device Sequence Number: 1
• Product Code: HBF
• 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
• Report Date: 10/20/2017

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 Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: AD03 ATTACHMENT, S/N UNK, EM200, S/N UNK
• Patient Outcome(s): Other