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

Model Number DM0010FAA

Device Problem Device Remains Activated (1525)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Radiation Exposure, Unintended (3164)

Event Date 11/22/2016

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.Based on information obtained from the surgeon on follow up, the likely cause of this issue was use error.This dm0010faa perforator with lot number 215/16 was manufactured by (b)(4).The device history records were reviewed by (b)(4) 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.(b)(4).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 during the procedure the perforator did not stop and the doctor stated there was a potential for injury.At the time of this report, no patient impact was reported.On initial follow up the devices used in the procedure were identified.The patient received a dermal tear and a venous injury.The rep stated that the surgical procedure was completed and the patient is doing fine now.The patient's age was also reported.On further follow up it was reported per the surgeon, she was not sure if the perforator stopped or not.While she was using it, she noticed some venous bleeding and became concerned.When she stopped use, she noticed that some of the inner table had been pushed in and may have torn the dura.She reported this as her only real concern and thought it could have been related to the patient anatomy or something she did.The event date was also provided.The patient had a follow up ct scan that the surgeon determined was pristine.The patient did not need follow up due to this event.No further information regarding patient information was provided.It was reported that the devices would not be released by the hospital.

• Brand Name: EASYDRILL
• 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 ; 77886587
• MDR Report Key: 6196929
• MDR Text Key: 63066534
• Report Number: 1625507-2016-00049
• Device Sequence Number: 1
• Product Code: HBF
• 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
• Report Date: 12/21/2016

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: 11/22/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2016
• 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
• Treatment: AD03 PERFORATOR DRIVER S/N (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR