Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Information (3190)
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Event Date 11/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign county: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11492; 0001825034 - 2018 - 11496; 0001825034 - 2018 - 11500; 0001825034 - 2018 - 11501.
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Event Description
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It was reported that during inspection of the shipment, part of the seal on the sterile package was peeled off.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Udi : (b)(4).Reported event was confirmed by review of photographs received.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event is likely to be equipment not operating properly and/or operator not following the work instruction provided.A corrective action has been initiated to address this issue.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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