Catalog Number 51-107170 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
Injury
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Event Description
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It was reported that when opening the implant for use, the implant was found to be jammed through the inner slip and hard plastic shell of the packaging.There was no harm or health impact to the patient.Attempts have been made and no further information is available.
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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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Manufacturer Narrative
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(b)(4).Visual examination of the returned product/provided photos identified damage to the sterile packaging (blister and pouch).Sterility has been compromised.The reported event has been confirmed by the evaluation of the returned product and provided pictures.Dhr was reviewed and no discrepancies related to the reported event were found.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design 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 additional event information to report at this time.
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Search Alerts/Recalls
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