Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(udi): n/a.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.Will be returned.
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Event Description
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It was reported that during total shoulder procedure the stem was protruding through the packaging.Surgeon used larger size to complete the procedure.Attempts have been made and there is no additional information available at this time.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed via the visual evaluation of the returned product which confirmed that the stem implant has poked through both the inner and outer cavities.Sterility was compromised.The corners of the carton box are slightly deformed and creased.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage.This event was farther investigated through the capa process.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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