Catalog Number 00885100206 |
Device Problem
Gas/Air Leak (2946)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an unknown time on an unknown date, that there was a leakage at the coupling portion of the hose.The small o-ring did not make the seal.There was no information communicated regarding harm, injury, or delay.Due diligence is in progress.No additional information is available at this time.
|
|
Manufacturer Narrative
|
This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01590.G2- event occurred in france.
|
|
Manufacturer Narrative
|
This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
|
|
Event Description
|
It was reported that before surgery that there was a leakage at the coupling portion of the hose.The small o-ring did not make the seal.There was no harm or injury to the patient and no reported delay.Due diligence is complete.No additional information is available.
|
|
Event Description
|
No additional information is available regarding the incident.
|
|
Manufacturer Narrative
|
This event is recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01591-2.No product was returned, only pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is not 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.
|
|
Search Alerts/Recalls
|