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Catalog Number 71177203 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2018 |
Event Type
malfunction
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Event Description
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It was reported that universal handle did not hold onto multi-parallel pin guide.Therefore, surgeon had to use without handle.Surgeon had to divert from the original procedure to complete the surgery and there was a delay reported of less than 30 minutes.Patient was not affected, surgery finished fine and patient did well intra-operatively.
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Manufacturer Narrative
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The associated complaint device was returned and evaluated.A visual inspection of the returned universal handle indicated damage to the ball plunger and along the body of the device.This device was manufactured in 2008, showing signs of wear/use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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Search Alerts/Recalls
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