Model Number N/A |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that the device seized.Event occurred outside of surgery on an unknown date.There was no reported patient harm, or delay.Due diligence is in progress, no further information is available at this time.
|
|
Manufacturer Narrative
|
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone: (b)(6).G2 foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device not yet returned.
|
|
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 device would not turn on.The motor and needle bearing were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional information is available.
|
|
Search Alerts/Recalls
|