Catalog Number 42527600505 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been returned for examination.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 the device was identified fractured in the distributor office.No patient or surgical involvement.No further information is available at this time.
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Event Description
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No further information is available at this time.
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Manufacturer Narrative
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(b)(4).Examination of the returned complaint product confirms the reported wear from repeated use and post fracture.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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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Search Alerts/Recalls
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