Model Number N/A |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: cup positioner 2: 0001822565-2019-01410.
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Event Description
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It was reported that this instrument broke.No known patient involvement.Attempts have been made and no further information has been provided.
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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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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual inspection of lot 61953843 identified the thread tip damaged.The devices were manufactured in dec 2011 and may 2014 with an approximate field service ages of 8 years 3 months and 5 years respectively.It is unknown how many times the device was used.Device history record (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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