Catalog Number 5400300000 |
Device Problem
Overheating of Device (1437)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/24/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during a procedure at the user facility, the core impaction drill was overheating.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
|
|
Event Description
|
It was reported that during a procedure at the user facility, the core impaction drill was overheating.The procedure was completed successfully without a clinically significant delay; no medical intervention and no adverse consequences were reported.
|
|
Manufacturer Narrative
|
The device is available for evaluation but has not yet been received.Additional information may be submitted once the device is received and the quality investigation is complete.
|
|
Manufacturer Narrative
|
Date of product return provided.The failure for overheating was confirmed by the repair technician through functional evaluation, disassembly, and visual inspection.The components of the drill were corroded, including the motor and spindle housing.
|
|
Search Alerts/Recalls
|