Catalog Number 283913000 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Awaiting sample: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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While turning out the mixing bowl from cement reservoir, the cement came out like a sausage and didn't stay on place at cement reservoir.The cement hardened faster as usual.
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Manufacturer Narrative
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Visual examination of the returned device found cement in the reservoir which appears to have thickened during insertion into the reservoir.The cement is not homogenous and has flecks of white dust on its surface.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the cement setting prematurely cannot be determined from the samples and the information provided.A potential root cause may be environment factors in regards to the storage of the cement.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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