MalfunctionHTT
BURR, OVAL, 4MM X 69MM, STERILE
Received Sep 17, 2008 · Event occurred Sep 17, 2008
Report 1182311 · MDR key 1182311
Device
Generic name
Drill Tip
Manufacturer
OsteomedModel number
450-6140-SPCatalog number
450-6140-SP
Lot number
*
Product problems
- Method, improper/incorrect
- Tip breakage
Patient
16 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
OSTEOMED DRILL LOADED WITH OSTEOMED BURR REF # 450-6140-SP; OVAL BURR TIP SNAPPED OFF SHAFT WHEN BURR MADE CONTACT WITH BONE.====================== MANUFACTURER RESPONSE FOR BURR, OVAL, 4MM X69MM, STERILE, OSTEOMED======================FIELD REP NOTIFED. HE WILL COLLECT THE BURR THIS WEEK FOR COMPANY INVESTIGATION. HE STATES, "THERE IS A SHORTER BURR WHICH MAY HAVE BEEN A BETTER SELECTION FOR THE PROCEDURE". HE WILL EDUCATE THE SURGEON.