Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Information (3190)
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Event Date 07/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001822565 - 2017 - 05565, 0001822565 - 2017 - 05566, 0001822565 - 2017 - 05567, concomitant products: 00151603040 impactor, lot 62976303; 00151603044 impactor, lot 62171803; 00151603048 impactor, lot 61924297.The device has not been returned for evaluation at this time.Follow up attempts are being done for product return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the instrument is not functioning as intended.No patient consequence was reported and no additional information is 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.Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.As returned, the device exhibits wear & tear to the connecting features.There are particles embedded on the dome.Dimensional measurements are conforming.Device history record (dhr) was reviewed and no discrepancies were found.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay corrected and additional information.Corrected: previously submitted an expiration date.Product is not a sterile device therefore no expiration date.This information does not change the previously submitted investigation.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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