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 03/21/2018

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 767/16 was manufactured 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 was reviewed.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 did not disengage.No patient impact reported.On followup it was reported that there was a delay in the surgery due to repair of cranial lesion however it was also stated that current status of the patient is alive with injury.Additional information is currently being requested.

Manufacturer Narrative

Report not confirmed.Evaluation could not reproduce.The reported malfunction continues to run.No other anomalies were identified.This (b)(4) perforator with lot number 767/16 was manufactured 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 was reviewed.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.

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed as the device was returned disassembled.When the device is used with rotation counterclockwise it will cause the drill bit to disassemble.No other anomalies were identified.This (b)(4) perforator with lot number 767/16 was manufactured 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 was reviewed.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 did not disengage.No patient impact reported.On followup it was reported that there was a delay in the surgery due to repair of cranial lesion however it was also stated that the patient had no other impact reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 -39; BR 09980-39
• Manufacturer (Section G): MICROMAR INDUSTRIA E COMERCIO LTDA; cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980 -39; BR 09980-39
• Manufacturer Contact: natalia matos ; cnpj: 53.168.142/0001-29; av. marginal ao corrego da ser; sao paulo,sp 09980-39 ; BR 0998039 ; 140575722
• MDR Report Key: 7449771
• MDR Text Key: 106137039
• Report Number: 1625507-2018-00022
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543081
• UDI-Public: 07898959543081
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2018
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 767/16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other