Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/02/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).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.Product not yet received.
|
|
Event Description
|
It was reported that a scrub nurse noticed a hair in the sterile package.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected
updated: d9; g3; h2; h3; h4; h6
reported event could not be confirmed.Visual evaluation of the returned product identified that product was returned with opened sterile packaging and there is debris in sterile packaging.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported item and lot combination.The likely condition of the device when it left zimmer biomet, or the root cause of the reported event cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|