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

Lot Number J8969C

Device Problem Break (1069)

Patient Problems Perforation (2001); Foreign Body In Patient (2687)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

The perforator was being used for a left frontal craniotomy with excision of brain tumor.It is to be noted that the perforator reached to a point where it did not function as expected once it had perforated the inner table of the bone.It appears that the perforator broke off and dug further into the patient's skull, the surgeon had to retrieve broken pieces and had to use other tools to remove the broken perforator from the patient's skull.

• Brand Name: CODMAN DISPOSABLE PERFORATORS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11365119
• MDR Text Key: 233079966
• Report Number: 11365119
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J8969C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 99