CORE INTRA-ORAL BLADE
Received Dec 8, 2010 · Event occurred Nov 11, 2010
Report 9616696-2010-00366 · MDR key 1950141
Device
Generic name
Saw Blades & Accessories
Manufacturer
Stryker Ireland Ltd.Catalog number
5400031034
Lot number
10169027
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ORAL SURGERY IN THE MANDIBULAR RAMUS REGION, THE BLADE BROKE AT THE WELD BETWEEN THE BLADE AND THE SHANK. IT WAS FURTHER REPORTED THAT AS A RESULT OF THIS BREAKAGE, A RECIPROCATING BLADE WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TECHNIQUE WAS CHANGED FROM A PERPENDICULAR OSTEOTOMY TO HORIZONTAL OSTEOTOMY AS A RESULT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS MDR WAS RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE BLADE BROKE AT THE WELD BETWEEN THE BLADE AND THE SHANK. THE RETURNED BLADE MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECS WERE MET. MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.