MAUDE Adverse Event Report: CODMAN* DISP PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/07/2012

Event Type  Injury  

Event Description

While surgeon was drilling the cranium, the perforator didn't stop when it reached the dura.(sales rep confirms this device should block when it reached the dura).Fortunately there was any damn on the dura of patient.Please note the patient's bone was not particularly sound.We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4).A follow-up is being generated because is being reclassified from malfunction to serious injury.

Manufacturer Narrative

We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4).A follow-up is being generated because is being reclassified from malfunction to serious injury.

• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3772148
• MDR Text Key: 4376114
• Report Number: 1226348-2014-11419
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 26-1221
• Device Lot Number: BE0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2012
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 04/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention