Catalog Number 51-105120 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/08/2020 |
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 # 51-104150/ tprlc 133 t1 pps ho / lot # 3838102.Item# 51-105150/ tprlc xr t1 pps / lot # 2867459.Item# 51-105150/ tprlc xr t1 pps / lot# 2867456.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01819, 0001825034-2020-01820, 0001825034-2020-01824.
|
|
Event Description
|
It was reported during circulation of product, sterile packaging was found to be damaged.There was no patient involvement.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.Evaluation of the returned products confirmed the sterile packaging blister is damaged.Therefore, the reported event is confirmed and sterility of the product is intact.Dhr was reviewed and no discrepancies relevant to the reported event were found the root cause of the reported event it likely to be damage during transit.The event is being reviewed through the capa process.The device evaluation found no reportable malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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
|