Catalog Number 12-151307 |
Device Problem
Delivered as Unsterile Product (1421)
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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.Reported packaging damage event was confirmed via visual examination.It was identified the packaging was damaged and/or opened at an unknown time.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.The likely condition of the product when leaving zimmer biomet was conforming to specifications.It cannot be determined when and where the sterile cavity was opened.Therefore, the 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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