MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN; CRANIAL PERFORATOR, DISPOSABLE

Model Number 26-1221

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2013

Event Type  No Answer Provided  

Event Description

When drilling a right frontal burr hole, the burr became disconnected from the pneumatic anspach driver.The burr had gone through the skull and stopped at the membrane when it became disconnected.The surgeon is very familiar with this device and has never seen this.There was no injury to the patient.

• Brand Name: CODMAN
• Type of Device: CRANIAL PERFORATOR, DISPOSABLE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 3646837
• MDR Text Key: 4181687
• Report Number: 3646837
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2014

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?: *
• Device Operator: Physician
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: FF010S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 64 YR