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

Model Number 26-1221

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

While creating burr holes with the codman perforator, the drill bit drilled though the dura and (per the surgical resident) damaged a small amount of brain tissue.The attending surgeon was made aware.

• Brand Name: 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: 6452760
• MDR Text Key: 71505720
• Report Number: 6452760
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26-1221
• Device Lot Number: H42388
• Other Device ID Number: 26-1221
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR