Catalog Number 0607687000 |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/21/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during a procedure the autoplex system stopped mixing before the cement was mixed completely, which caused a 30-45 minute delay in the procedure.It was reported that no additional anesthesia was required and that the procedure was completed utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
|
|
Manufacturer Narrative
|
During the evaluation of the device, the internal components disclosed that the threaded shaft did not complete the final turn of the thread; the strip feature stripped sooner than expected.The device was discarded by the manufacturer.
|
|
Event Description
|
It was reported that during a procedure, the autoplex system stopped mixing before the cement was mixed completely, which caused a 30-45 minute delay in the procedure.It was reported that no additional anesthesia was required and that the procedure was completed utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
|
|
Manufacturer Narrative
|
A follow up report will be filed after the quality investigation has been completed.
|
|
Search Alerts/Recalls
|