Catalog Number 2101-0005 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2015 |
Event Type
malfunction
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Event Description
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It was reported that; the sales rep reports that during the procedure that he was sitting in on when introducing cement into the patient, the material set within approximately 30 seconds, as opposed to the usual time.They attempted to use a second unit and the same issued happened with that as well.
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Manufacturer Narrative
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Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: device history review indicated all devices accepted into final stock met specifications.Per additional email correspondence; it was reported that the product was allowed to equilibrate to room temperature prior to use for 45min, the product was stored in standard refrigerator temp (45f) and room was 69 degrees.Sales rep also indicated that the product was not injected into the mixtip and sitting for any period of time prior to injection.Conclusion: the plausible root cause for the reported event is multifactorial.
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Event Description
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It was reported that; the sales rep reports that during the procedure that he was sitting in on - when introducing cement into the patient, the material set within approximately 30 seconds, as opposed to the usual time.They attempted to use a second unit and the same issued happened with that as well.
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Search Alerts/Recalls
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