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

Model Number 26-1221

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Event Description

During left temporal craniotomy for temporal mass suspected brain tumor, the surgeon was creating 4 burr holes.On the last burr hole creation the perforator did not stop.The surgeon immediately pulled the drill back without injury to the underlying dura.The perforator has built in stop mechanism so that when the inner portion of the skull is breached it is supposed to stop.The drill's diameter is approximately the size of a nickel.This failure could have injured the brain matter.There was no delay in the case.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 5531186
• MDR Text Key: 41313670
• Report Number: 5531186
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: 26-1221
• Device Lot Number: DH004S
• 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: 03/23/2016
• Device Age: 0 DY
• Event Location: Other
• Date Report to Manufacturer: 03/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR