inforMED
MalfunctionHTT

MIS CURVED BUR, 3.0MM NEURO

Received Apr 30, 2009 · Event occurred Apr 2, 2009

Report 9616696-2009-00049 · MDR key 1427385

Device

Generic name

Surgical Burs, Drills, Trephines 7 Accessories

Catalog number

8420107030

Lot number

UNK

Product problems

  • Break

Patient

UNK

  • No Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THAT THE HEAD OF THE BUR BROKE. IT WAS FURTHER REPORTED THAT BACK UP EQUIPMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE.

Additional Manufacturer Narrative

DEVICE RETURNED, AWAITING EVALUATION OF DEVICE. IN ADDITION, NO LOT NUMBER INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION.