Catalog Number 51-107090 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 01/06/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.(b)(4).Concomitant medical products: item# 51-145120/trplc xr mp/ lot # 6006852.Item # 51-102040/ tprlc xp fp /lot # 3455231.Foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00413, 0001825034-2020-00414.
|
|
Event Description
|
It was reported during inspection of the product at the distributorship, that the sterile packaging was noted to be damaged.There was no patient or hospital involvement.Attempts have been made an no further information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed by visual inspection of the returned products identified the outer carton boxes were damaged, consistent with transit damage.The outer cavities were damaged.The sterility of the products still remains intact.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|