MAUDE Adverse Event Report: AESCULAP, INC. KERRISON RONGEUR

Model Number FF773R

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/03/2016

Event Type  Injury  

Event Description

Screw came off from a kerrison rongeur.A bone instrument used to cut or bite excess bone that would be in the way for implantation in the cervical spine area.The screw was recovered before any procedure was performed and closure of the wound site.

• Brand Name: KERRISON RONGEUR
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 5690800
• MDR Text Key: 46380699
• Report Number: MW5062570
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2016

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
• Device Operator: Health Professional
• Device Model Number: FF773R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR