MalfunctionHTT
5.0MM 12 FLUTE BARREL BUR, HOLLOW, FORMULA (5BX)
Received Jul 9, 2012 · Event occurred May 22, 2012
Report 2648666-2012-00230 · MDR key 2656290
Device
Generic name
Formula Bur
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0375951112
Lot number
12072CD2
Product problems
- Fracture
- Noise, Audible
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SUB-ACROMIAL DECOMPRESSION, THE SURGEON HEARD STRANGE NOISES. HE REMOVED THE DEVICE FROM THE PATIENT AND WHILE TESTING IT, OUTSIDE THE PATIENT, THE HEAD OF THE PRODUCT FRACTURED. IT WAS REPORTED THAT ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT AND WITHOUT DELAY.