CORE INTRA-ORAL BLADE
Received Jun 17, 2010 · Event occurred May 25, 2010
Report 9616696-2010-00250 · MDR key 1757122
Device
Generic name
Saw Blades And Accessories
Manufacturer
Stryker Ireland Ltd.Catalog number
5400031034
Lot number
10060017
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BLADE BROKE AT THE ARBOR DURING AN ORAL SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE BROKE AT THE JOINT TO THE ARBOR. MEASUREMENTS CARRIED OUT ON THE BLADE CONFIRMED THAT ALL FEATURES CONFORMED TO REQUIRED SPECIFICATION. A DOCUMENTATION REVIEW CONFIRMED THAT NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE FOR THE BREAKAGE IS UNDETERMINED.