MAUDE Adverse Event Report: UNKNOWN BURR, ORTHOPEDIC

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported during a routine field service maintenance visit, a broken bur was observed inside the attachment.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement or adverse consequences as a result of this event.0001811755-2016-02805.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BURR, ORTHOPEDIC
• Type of Device: BURR, ORTHOPEDIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529484
• MDR Text Key: 321411934
• Report Number: MW5136410
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1