Model Number N/A |
Device Problems
Device Inoperable (1663); Failure to Disconnect (2541)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of device history records show the lot released with no recorded anomaly or deviation.The device was returned in a biohazard bag.The engineer advised the stuck pin would not cause the driver not to turn.The engineer was able to turn the knob on the driver through the biohazard bag and the driver did rotate.Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported "the temporary pin jammed up the driver and it was unable to turn." the surgery was completed, there was no patient injury and a ten minute surgical delay.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned in a biohazardous condition.Upon visual inspection, it can be seen that the blade is still in the driver.Functional testing through the bag (attempting remove the blade and rotate the driver through the bag) confirms that the blade could not be removed and the blade would not turn.Further testing and inspection could not be completed due to the bio-hazardous condition of the products.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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Search Alerts/Recalls
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