MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION CODMAN DISPOSABLE PERFORATOR AND CLUTCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number CODMAN PERFORATOR AND CLUTCH

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Drill bit plunged into the bone before coming apart from drill while trying to operate drill.Surgeon was able to keep the bit from puncturing brain tissue.

• Brand Name: CODMAN DISPOSABLE PERFORATOR AND CLUTCH
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• MDR Report Key: 18347045
• MDR Text Key: 330872512
• Report Number: MW5149321
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CODMAN PERFORATOR AND CLUTCH
• Device Lot Number: 7124525
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male