Catalog Number 47248405050 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign - event occurred in (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.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 approximately three (3) weeks ago, as the cardboard outer packaging was being removed from the znn screw, the inner plastic barrier was compromised.The box was opened at the exact place it is perforated, but the inner plastic was broken at the same time.No surgery occurred and no patient involvement.Attempts have been made and no further information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the provided picture identified that the extremity of the sterile cavity is bent along the folding line of the cardboard box and resting within the folded carton box portion.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event it likely to be damage during transit.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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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found the outer carton and the outer sterile blister are damaged.Due to the damage to the sterile blister, the sterility of the product has been breached.The root cause of the event remains the same as previously reported.The root cause of the reported event is likely to be damage during transit.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 additional event information is available at the time of this report.
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Search Alerts/Recalls
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