ION NITRIDED CAST CUTTER BLADE
Received Oct 18, 2010 · Event occurred Sep 17, 2010
Report 9616696-2010-00302 · MDR key 1879811
Device
Generic name
Cast Removal Instrument
Manufacturer
Stryker Instruments KalamazooCatalog number
0840023000
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE CAST CUTTER AND BLADE WERE RETURNED TO THE MANUFACTURER FOR EVAL. A CUT TEST ON THE BLADE FOUND THAT THE BLADE WAS A LITTLE LOOSE. THE COLLAR HAD MARKINGS INDICATING IT WAS SEATED INCORRECTLY. IF THE RETAINING RING ISN'T SEATED CORRECTLY, IT IS POSSIBLE THAT THE SCREW COULD BACK UP CAUSING THE BLADE TO BECOME LOOSE. ADDITIONAL INFO ON THE DETAILS SURROUNDING THIS EVENT HAS BEEN REQUESTED FROM THE ACCOUNT. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFO IS RECEIVED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE REMOVING A CAST USING THE CAST CUTTER WITH A ION NITRIDED CAST CUTTER BLADE, THE PT RECEIVED A LACERATION ON THE LEG. ADDITIONAL INFO SURROUNDING THIS EVENT HAS BEEN REQUESTED FROM THE ACCOUNT. IT IS UNK AT THIS TIME WHAT TYPE OF TREATMENT WAS GIVEN TO THE PT AS A RESULT OF THIS EVENT.