MAUDE Adverse Event Report: CODMAN / INTEGRA LIFESCIENCES CORPORATION CODMAN PERFORATOR DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that the perforator drill would not stop despite taking foot off the pedal.It was reported that an additional intervention was performed and the codman perforator broke into two pieces with one half retained in a burr hole in the patient¿s cranium.A hole was then cut around the attachment to remove it from the patient¿s head.The procedure was completed with the backup product.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CODMAN PERFORATOR DRILL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN / INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17510313
• MDR Text Key: 321094571
• Report Number: MW5123009
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1