Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The results of the investigation are as follows: review of the most recent repair record determined he motor speeds were low and erratic, the calibration was out at the 0 reading, and the control bar and head were damaged; however, the repair was not completed because the customer denied the repair quote - returned to customer unrepaired.A definitive root cause cannot be determined.The event is confirmed.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 unit was found in need of repair.No additional information was reported.During investigation, it was found that the motor speeds were low and erratic, no adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.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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