MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Device Problems Failure to Auto Stop (2938); Protective Measures Problem (3015)

Patient Problem Brain Injury (2219)

Event Date 11/12/2021

Event Type  Injury  

Event Description

The att mr8 perforator driver, midax rex mr 8 pneumatic drill and codman disposable perforator failed to stop.This caused the drill bit to go through the cranium and harm the brain tissue underneath.Fda safety report id # (b)(4).

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• MDR Report Key: 12835207
• MDR Text Key: 281023303
• Report Number: MW5105409
• Device Sequence Number: 3
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 11/15/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other