Catalog Number 6633-7-744 |
Device Problems
Break (1069); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/21/2014 |
Event Type
malfunction
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Event Description
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(b)(4) stated: during total knee procedure, the patella clamp broke while in use.Instrument was removed from operative field, and given to materials coord.Xray taken, and reported as negative by radiology.Doctor aware of xray results.No harm to pt.Stryker rep also present at time of incident.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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Corrected data: the device was not returned for evaluation.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.Not returned.
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Event Description
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User facility report # (b)(4).Stated: during total knee procedure, the patella clamp broke while in use.Instrument was removed from operative field, and given to materials coord.Xray taken, and reported as negative by radiology.Doctor aware of xray results.No harm to pt.Stryker rep also present at time of incident.
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Search Alerts/Recalls
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