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

Model Number DM0210FAA

Device Problems Device Remains Activated (1525); Vibration (1674); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.This dm0210faa easydrill cranial perforator with unknown lot number was manufactured by micromar.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 track and trend this complaint type.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.It was reported that there was no patient impact.It was also reported that there was no additional intervention, there was a procedure delay for few minutes, and it was completed using a backup device.On follow up, no further information can be provided regarding the status of the patient post-surgery.It was also reported that during the delay, a backup device was prepared and used to perform the burr hole creation.Additional information provided that the device was vibrating and became misaligned while turning.

• 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 09980-39 ; 140575722
• MDR Report Key: 10994809
• MDR Text Key: 246738705
• Report Number: 1625507-2020-00231
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM0210FAA
• Device Catalogue Number: DM0210FAA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/12/2020
• 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: N
• Patient Sequence Number: 1