MAUDE Adverse Event Report: AESCULAP AG GOLD TIPPED KERRISON #1; RONGEUR

Device Problem Break (1069)

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

Event Date 03/28/2016

Event Type  malfunction  

Event Description

During an anterior cervical discectomy procedure - the tip of the device broke off.The broken tip was suctioned from the surgical site.Instrument taken off the field.

• Brand Name: GOLD TIPPED KERRISON #1
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG; 3775 corporate parkway; center valley PA 18034
• MDR Report Key: 5716727
• MDR Text Key: 47103074
• Report Number: 5716727
• Device Sequence Number: 1
• Product Code: HTX
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2016
• Event Location: Other
• Date Report to Manufacturer: 05/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR