4.0MM 6 FLUTE BARREL BUR- HOLLOW, FORMULA (5BX)
Received Jan 17, 2008 · Event occurred Jan 7, 2008
Report 2648666-2008-00005 · MDR key 982887
Device
Generic name
Barrel Bur
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0375941000
Lot number
07338CE2
Product problems
- Break
- Material Fragmentation
Patient
UNK
- No Information
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT DURING AN ANKLE FUSION PROCEDURE, THE HOOD OF THE BUR BROKE AWAY INSIDE THE PT AND SMALL FRAGMENTS WERE SEEN IN THE WOUND. IT IS REPORTED THAT THE CONSULTANT AND REGISTRAR COMPLETED THE PROCEDURE SUCCESSFULLY AND FLUSHED THE WOUND TO COMPLETE THE PROCEDURE. IT IS FURTHER REPORTED THAT THE CUSTOMER REFUSES TO USE THE REMAINDER OF THEIR STOCK WITH THE SAME LOT NUMBER. (4 BOXES).
Additional Manufacturer Narrative
DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER. ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.