InjuryHTW
AFFINITI GLENOID STARTER/PERIPHERAL DRILL BIT
Received May 15, 2014 · Event occurred May 7, 2014
Report 3004983210-2014-00011 · MDR key 3839054
Device
Product problems
- Break
- Difficult to Remove
Patient
Not reported
- Tissue Damage
Narrative
Additional Manufacturer Narrative
THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.
Description of Event or Problem
AFTER CLOSING PT, SURGEON TOOK X-RAYS AND NOTICED AN UNIDENTIFIED PIECE IN THE BODY; PT WAS REOPENED, AND THE PIECE WAS REMOVED. IT WAS IDENTIFIED AS PART OF A DRILL BUT THAT BROKE DURING USE. SURGEON HAD NOT NOTICED THAT THE DRILL BIT HAD BROKEN DURING USE.