Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2019 |
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: 0001825034 - 2019 - 01576.
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Event Description
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It was reported that the patient underwent a shoulder procedure.While the surgeon was attempting to drill the hole the drill bit seized up inside the vrs drill guide.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of the product returned.Visual inspection showed that the drill seized in the vrs inserter.As the drill was seized no dimensional analysis was performed on the vrs inserter.Dimensions taken on the drill are found to be confirming.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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