MAUDE Adverse Event Report: ACRA-CUT, INC. ACRA-CUT; DRILL BIT CRANIAL PERFORATOR

Lot Number 8455

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

The cranial acracut perforator was recently introduced to address a problem with drill bits "plunging" (when the drill bit doesn't stop).The residents have complained of some chatter from the acracut drill bit, but have experienced episodes when the bit does not go all the way through the cranium.The operating room leadership and neurosurgery department quality chair has been informed and the product that malfunctioned is being looked at by bio-med.

• Brand Name: ACRA-CUT
• Type of Device: DRILL BIT CRANIAL PERFORATOR
• Manufacturer (Section D): ACRA-CUT, INC.; 989 main street; acton MA 01720
• MDR Report Key: 3766473
• MDR Text Key: 4374026
• Report Number: 3766473
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 8455
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE BONE (CRANIUM). A SECOND RESIDENT ALSO STATED; WHILE STARTING TO PERFORM A RIGHT CRANIOTOMY FOR; HEMATOMA IN THE OPERATING ROOM, THE PERFORATOR; MALFUNCTIONED X2. THE NEUROSURGERY RESIDENT STATED; THAT THE PERFORATOR STOPPED WHEN GOING THROUGH; THE SAME.
• Patient Age: 73 YR