DRILL/REAMER
Received Jun 2, 2016 · Event occurred May 9, 2016
Report 3003604053-2016-00019 · MDR key 5694857
Device
Product problems
- Failure to Power Up
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.
Additional Manufacturer Narrative
NO EVALUATION CONDUCTED TO DATE, AWAITING RECEIPT OF DEVICE. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WOULD NOT POWER ON. THERE WAS NO BACKUP DEVICE AVAILABLE AND A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.