MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS LLC ZB-136 4MM 7.9MM OVAL CUT BUR SURGICAL CARBIDE LATEX; BURR, ORTHOPEDIC

Model Number 046029 ZB136 +M138ZB-1361$

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Doctor had used the needle passing bur for the procedure and noticed that the tip had broken off.Xray was performed and the doctor was able to identify the location of the broken bur tip.The tip was removed and the procedure was finished.

• Brand Name: ZB-136 4MM 7.9MM OVAL CUT BUR SURGICAL CARBIDE LATEX
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS LLC; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 10913714
• MDR Text Key: 218511833
• Report Number: 10913714
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2020

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: 046029 ZB136 +M138ZB-1361$
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA