MAUDE Adverse Event Report: MICROMAR INDÚSTRIA E COMÉRCIO LTDA EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

Device Problem Failure to Auto Stop (2938)

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

Event Date 03/21/2021

Event Type  malfunction  

Event Description

During surgery at skull perforation to achieve access to operative site.The surgeon reported to the surgical tech assisting and myself in the room to make the coordinator aware that the midas rex safety feature malfunctioned.Typically, the drill will stop to prevent injury to the brain, however, it did not stop.Doctor did report that no injury to the patient occurred.Perforator disposable piece medtronic easy drill cranial perforator: ref# dm0010faa, perforator reusable drill attachment: (b)(4), medtronic reusable drill handpiece: (b)(4), medtronic drill machine on neuro cart with drills and bovies; serial number: (b)(4).

• Brand Name: EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDÚSTRIA E COMÉRCIO LTDA; 12343 nw 25th street; coral springs FL 33065
• MDR Report Key: 11559598
• MDR Text Key: 241949437
• Report Number: 11559598
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA