Model Number N/A |
Device Problems
Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)
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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).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.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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It was reported that the product was damaged upon receipt.The seal of the packaging was removed as well.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Upon further review it was found that this malfunction has not been previously reported as causing or contributing to an adverse event.Therefore, the initial report was filed in error and should be voided.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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Manufacturer Narrative
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Complaint packaging sample was evaluated and the reported event was confirmed.The product/implant was not returned; but its packaging was returned and from returned packaging it was determined that, the box doesn't exhibit any damage, the inner and outer tyvek lids are torn open from the middle.There is dried glue on the sealing edge of the thermal cavities where the tyvek lid was sealed.The seal on the carton box is still intact but the box label spanning the two sides of the carton is torn at the corner.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.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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Manufacturer Narrative
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The follow-up report is being submitted to relay additional information.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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