Model Number N/A |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Patient Involvement (2645)
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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.
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Event Description
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It was reported by a distributor that there was packaging damage with sterility barrier potentially compromised.There was no patient involvement.No adverse events have been reported as a result of the malfunction.
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Event Description
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No further information available at the time of this reporting.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported packaging damage event was confirmed via visual examination.It was identified the packaging was damaged in transit.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause 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.
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Search Alerts/Recalls
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