inforMED
MalfunctionHTT

4 MM HIGH SPEED TAPERED DIAMOND BURR

Received Aug 27, 2015 · Event occurred Jul 23, 2015

Report 5034322 · MDR key 5034322

Device

Generic name

Burr

Catalog number

1883672HS

Lot number

0209598413

Product problems

  • Break
  • Component Missing

Patient

43 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

ENDONASAL SINUS SURGERY WAS IN PROGRESS WHEN THE HIGH SPEED TAPERED DIAMOND, 4MM 70 DEGREE, BURR'S TIP (REF# (B)(4)/LOT#0209598413) WAS NOTED TO BE MISSING. NO PATIENT/STAFF HARM. ADDITIONAL BURRS OBTAINED FOR PROCEDURE TO CONTINUE. TWO MORE ENDONASAL DRILL ATTACHMENTS FROM THE SAME MANUFACTURER/COMPANY BROKE DURING THE CASE: FIRST, REF#(B)(4)/ LOT#0209504794 - HIGH SPEED ROUND DIAMOND BURR, 5MM 15 DEGREE, BURR'S 䓠NECK BROKE AND THE TIP POPPED OUT WHILE IN USE. SECOND, REF#(B)(4)/ LOT#0209237919 - HIGH SPEED TAPERED DIAMOND BURR 4MM 70 DEGREE, BURR BROKE.