Model Number N/A |
Device Problem
Packaging Problem (3007)
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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).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; e1; g4; g7; h1; h2; h3; h4; h6 complaint sample was evaluated and the reported event was not confirmed.Only the shelf carton box and the device were returned for investigation; sterile packaging was not returned.The complaint cannot be verified.Device history record (dhr was reviewed and no discrepancies were found.The likely condition of the product when leaving zimmer biomet was conforming to specifications.A definite root cause of the reported issue cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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