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

Model Number 26-1221

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2020

Event Type  malfunction  

Event Description

While making burr hole with perforator, the tip completely stopped spinning and the perforator was unable to be removed from the skull.The surgeon said he needed another perforator because he could not remove the first one from patient¿s skull.The anspach handpiece was detached from the perforator tip by the surgeon, a second perforator was opened, attached to the anspach hand piece, and surgeon continued to make burr hole.Surgeon then was able to remove the first perforator from the patient¿s skull and stated that it stopped superficial to where it was supposed to, so no damage was done to the patient.Device sequestered.Procedure completed with no other issues.

• 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: 11214179
• MDR Text Key: 228174908
• Report Number: 11214179
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: J81G32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2021
• Date Report to Manufacturer: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29583 DA