MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.; RONGEUR, MANUAL

Model Number 53-4008

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Micro pituitary broke intraoperatively while doctor was using it on a cervical disc.The item was removed from the sterile field and given to materials coord.The wound was checked with microscope, all pieces accounted for.X-ray done and read by radiology.X-ray negative for instruments or from broken pituitary.Doctor aware of the x-ray results.No harm to the patient.

• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 4683358
• MDR Text Key: 5714992
• Report Number: 4683358
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 53-4008
• Device Catalogue Number: 53-4008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2015
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 52