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

Model Number 26-1221

Device Problems Mechanical Jam (2983); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

Surgeon was using the codman14mm disposable perforator.This drill bit is designed to engage the clutch when moisture is sensed therefore disengaging the drill.This is a safety feature to prevent the dura of the brain from being penetrated.During this surgery, the codman14mm disposable perforator malfunctioned and the dura was penetrated.The perforator then ceased up and was stuck in the skull.Surgeon had to use 2 more drill bits to release the perforator from the skull.The removal of the perforator took up valuable time which could have been used to more efficiently to remove the subdural hematoma in this emergent case.This malfunction could have hurt the patient significantly.

• Brand Name: CODMAN
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12951745
• MDR Text Key: 281847412
• Report Number: 12951745
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

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: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: 5727642
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 105 KG