MalfunctionLGG
ION NITRIDED CAST CUTTER BLADE
Received Dec 8, 2010 · Event occurred Nov 10, 2010
Report 9616696-2010-00363 · MDR key 1931447
Device
Generic name
Cast Removal Instrument
Manufacturer
Stryker Instruments CorkCatalog number
0840023000
Lot number
UNK
Product problems
- Overheating of Device
Patient
UNK
- Abrasion
- Erythema
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE BEGAN TO OVERHEAT DURING A SERIAL CAST REMOVAL, BEING USED WITH A CAST CUTTER HANDPIECE. THE CAST EXTENDED FROM KNEE TO ANKLE. UPON REMOVAL OF THE CAST, SLIGHT REDNESS AND A MILD ABRASION WAS FOUND ON THE PT'S LEG WHERE THE BLADE WAS BEING USED TO REMOVE THE CAST. NO ADDITIONAL TREATMENT WAS GIVEN TO THE PT DUE TO THE EVENT. NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE EVENT.
Additional Manufacturer Narrative
THE BLADE WAS DISCARDED BY THE ACCOUNT AND IS NOT AVAILABLE FOR INVESTIGATION.