Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event was initially reported on 0001822565-2020-02530.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows the drill pin stuck in a hole.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause 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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It was reported that the drill pin got stuck to the device during an initial procedure.Attempt for further information has been made, but no further information has been provided.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined that the initial report was submitted under wrong manufacturing site and should be voided.This report will be completed under manufacturing report number 0001822565-2021-01039.
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Event Description
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Upon receipt of additional information, it was determined that the initial report was submitted under wrong manufacturing site and should be voided.This report will be completed under manufacturing report number 0001822565-2021-01039.
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Search Alerts/Recalls
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