MalfunctionHTT
BURR, ORTHOPEDIC
Received Aug 12, 2023
Report MW5136410 · MDR key 17529484
Device
Generic name
Burr, Orthopedic
Manufacturer
UnknownProduct problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
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)