Catalog Number 51-105120 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01445, 0001825034-2020-01446, 0001825034-2020-01450.
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Event Description
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It was reported that during investigation of stock, the sterile packaging was damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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D4: udi #: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows that the outer sterile cavities have been damaged.Sterility has not been compromised on any of the products.Device history record (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.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.The event is being reviewed through the capa process.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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