Catalog Number 14-442002 |
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.Packaging was not returned for investigation.Only the device was returned.The reported issue of sterile packaging damage cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.This device is used for treatment.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further information available at the time of this reporting.
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Search Alerts/Recalls
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