Model Number N/A |
Device Problem
Material Frayed (1262)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
|
|
Event Description
|
It was reported that the device's wires were exposed.There is no additional information available.No adverse events were reported as a result of this malfunction.
|
|
Event Description
|
No additional event information.
|
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the plug harness assembly was replaced and resolved the reported issue.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
|
|
Search Alerts/Recalls
|