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Model Number 71272001 |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/23/2019 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, the cement gun did not progress forward handle sticks.Surgeon had to push cement out by hand.There was a two minute procedural delay.There was no smith & nephew available.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2017 and exhibits signs of extensive wear/usage.The functional evaluation confirmed the stated failure mode.The trigger mechanism is sticking and therefore will not function as intended.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there is no risk to the patient with using the cement gun manually, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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