MAUDE Adverse Event Report: ACRA-CUT, INC. DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Lot Number 10132

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Laceration(s) (1946)

Event Date 02/28/2022

Event Type  Injury  

Event Description

History of parkinson's disease.To surgery (b)(6) 2022 for bilateral dbs lead placement (dual arrays), electrode 'plcmt,' with mers (first array) - 61867, electrode 'plcmt,' with mers (each additional array) - 61868.During drilling of the burr holes with a perforator drill bit, the drill bit was supposed to stop drilling before it hit/cut the dura, however it didn't stop like it was supposed to and it hit/cut the dura.The surgery was going to have the dura and the brain entered anyway so there was no harm in this case with no additional care.It entered the dura too quickly; wasn't under control.Occurred in benign area of the brain.The surgery team retrieved another perforator drill bit before proceeding with drilling the other burr hole.No harm in this case but per surgeon if this would have occurred in a critical part of the brain it could have been disastrous.Fda safety report id# (b)(4).

• Brand Name: DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): ACRA-CUT, INC.
• MDR Report Key: 13691834
• MDR Text Key: 286852337
• Report Number: MW5107917
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White