Model Number N/A |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? not returned to manufacturer.
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Event Description
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It was reported foreign matter was identified in the device packaging prior to use.No further information available at the time of this reporting.
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Manufacturer Narrative
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- visual evaluation of the returned product identified that there is hair-like debris inside the sterile package.Both the sterile packagings have been opened when returned.The complaint has been confirmed by visual evaluation.- review of the device history records identified no related deviations or anomalies during manufacturing.- the likely condition of the product when it left zimmer biomet control cannot be determined.A definitive root cause of the reported event 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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