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

Model Number	26-1221
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While in use for right deep brain stimulator generator insertion, the perforator did not stop as it should and penetrated through the bone of patient's skull.There was no harm to the patient.

• Brand Name: CODMAN
• Common Device Name: DRILLS, BURRS, TREPHINES, ACCESSORIES
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8788948
• Report Number: 8788948
• Device Sequence Number: 13911454
• Product Code: HBF
• UDI-Device Identifier: 10886704005100
• UDI-Public: (01)10886704005100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/03/2019
• Report Date (Section F): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26-1221
• Device Catalogue Number: 26-1221
• Device Lot Number: J2403T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/03/2019