Catalog Number 419300 |
Device Problems
Defective Device (2588); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (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 has been reported that surgeon was attempting to extrude cement from optipac tube.While squeezing the trigger in the proper manner the piston would not advance and the result was that the cement would not eject from the delivery nozzle.
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Event Description
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It has been reported that the surgeon was attempting to extrude the cement from the optipac tube.While squeezing the trigger in the proper manner, the piston would not advance and the result was that the cement would not eject from the delivery nozzle.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The product analysis shows that the optigun works as attended.With the available information, the exact root cause of the event could not 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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