MAUDE Adverse Event Report: V MUELLER NEURO/SPINE KERRISON RONJURE

Model Number L-1173

Device Problem Component Missing (2306)

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

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Dr (b)(6) was using device kerrison #3 no problems noted when initially used.Then kerrison was then taken out of circulation.We are an (b)(6) center.Pt was undergoing surgery using the attached instrument.Noticed the screw was missing.The wound was inspected the screw was not in the pt.The instrument was returned to the company.

• Brand Name: KERRISON RONJURE
• Type of Device: KERRISON
• Manufacturer (Section D): V MUELLER NEURO/SPINE
• MDR Report Key: 4014013
• MDR Text Key: 4846505
• Report Number: 4014013
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2014

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: L-1173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2014
• Device Age: 2 YR
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 64