Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 04/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 that surgeon was drilling to use a screw with the g7 pps shell and the flexible drill broke, snapping just below the drill connection.Procedure was completed using another drill.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection of the returned device, the head had fractured from the shaft.The shaft shows warping.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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Event Description
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Attempts have been made and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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