MalfunctionHTT
BURR, ORTHOPEDIC
Received Oct 22, 2019 · Event occurred Sep 23, 2019
Report 9218310 · MDR key 9218310
Device
Generic name
Burr, Orthopedic
Manufacturer
Brasseler U.s.a. Medical, LlcCatalog number
14-C0108
Lot number
NQ5QZ
Product problems
- Break
- Detachment of Device or Device Component
- Physical Resistance/Sticking
Patient
5110 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BURR BROKE WHILE SURGEON WAS USING IT. THE SURGEON WAS USING IT ON A PEDICLE, AND THE BOTTOM END OF THE BURR BROKE OFF; IT WAS A CLEAN BREAK AND NO PIECES WERE IN THE PATIENT. THEN, THE TECHNICIAN COULDN'T GET THE REST OF THE BURR OUT OF THE PIECE OF EQUIPMENT THAT HOLDS IT; IT STAYED STUCK IN THE DRILL. OPERATING ROOM STAFF OBTAINED A NEW DRILL AND NEW BURR, AND THEN PROCEEDED WITH THE SURGERY AFTER A SHORT DELAY. THERE WAS NO INJURY TO THE PATIENT.