MAUDE Adverse Event Report: MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL CRANIAL PERFORATOR Ø14 X Ø11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

Elderly male with history of brain mass.Procedure: craniotomy, stereotactic left frontal craniotomy for tumor debulking.When attempting to use the medtronic easy drill cranial perforator, the drill bit became loose, unstable and wobbly.Device removed and another one worked without further issues.No known harm to patient.

• Brand Name: EASYDRILL CRANIAL PERFORATOR Ø14 X Ø11 X 3MM
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDUSTRIA E COMERCIO LTDA; 12343 nw 25th st; coral springs FL 33065
• MDR Report Key: 19201478
• MDR Text Key: 341264123
• Report Number: 19201478
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 07898959543593
• UDI-Public: (01)07898959543593(17)271005(10)2594/23
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2024

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: Health Professional
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 2594/23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male