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

Model Number 26-1221

Device Problems Break (1069); Failure to Shut Off (2939); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Codman perforator 14mm lot # j59k60 used with power midas rex legend perforator driver [serial number].During the creation of the first burr hole, the codman perforator did not automatically stop once perforation of cranium was completed.The perforator became 'stuck' in cranium and had to be removed from driver.The perforator came apart in 3 pieces when surgeon tried to pull perforator out of cranium.After successfully removing all pieces, surgeon noted that only 'old' blood from subdural was seen.Open further inspection of the patient's brain, surgeon stated that brain appeared normal with no signs of perforation of brain tissue.Manufacturer response for codman perforator, codman (per site reporter).They filed a complaint on their end.

• 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: 9785417
• MDR Text Key: 181935848
• Report Number: 9785417
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: J59K60
• 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: 02/20/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1