ION NITRIDED BLADE
Received Jun 11, 2019 · Event occurred May 14, 2019
Report 0001811755-2019-01950 · MDR key 8687208
Device
Generic name
Instrument, Cast Removal, Ac-powered
Manufacturer
Stryker Instruments-kalamazooCatalog number
0940023000
Lot number
UNKNOWN
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS INDICATE THAT EXCESSIVE USE OF THE BLADE ALONG WITH USING THE HANDPIECE IN A CONTINUOUS LINEAR MOTION MAY HAVE CONTRIBUTED TO THE ABRASION. THE IFU FOR CAST CUTTER BLADES HAS THE FOLLOWING WARNING; ¿CUT WITH AN UP AND DOWN MOTION. STRAIGHT CUTTING MAY CUT OR BURN THE PATIENT.¿ THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING THE REMOVAL OF A CAST IT WAS OBSERVED THAT THE CUSTOMER WAS CUT OR BURNED. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT FOLLOWING THE REMOVAL OF A CAST IT WAS OBSERVED THAT THE CUSTOMER WAS CUT OR BURNED. NO FURTHER INFORMATION WAS PROVIDED.