Catalog Number 6191-1-001 |
Device Problems
Clumping in Device or Device Ingredient (1095); Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the batch manufacturing records indicate packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
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Event Description
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During cement mixing, cement remained clumpy and did not thoroughly mix.No adverse consequences to patient, the cement was discarded and a new dose was mixed.
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Manufacturer Narrative
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An event regarding the appearance of the cement involving simplex bone cement was reported.Conclusion: it is reported that the bone cement remained clumpy and did not thoroughly mix.It is also reported that the cement was mixed with foreign ingredients.The instructions for use leaflet (ifu) packaged with the subject device indicates that inclusion of any extraneous material such as blood or sterilization solutions into the mix must be avoided.It has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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During cement mixing, cement remained clumpy and did not thoroughly mix.No adverse consequences to patient, the cement was discarded and a new dose was mixed.After submission of the complaint pi the person who reported this found out information not previously disclosed; that the cement was mixed off label with foreign ingredients.
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Search Alerts/Recalls
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