Catalog Number 09390110 |
Device Problems
Break (1069); Component Falling (1105)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/19/2015 |
Event Type
malfunction
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Event Description
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It was reported by stryker sales rep that the plugs broke inside a patient's femur during a procedure undergone at (b)(6) hospital.It was confirmed by phone by the sales rep that all three plugs remained inside the patient and will not be able to be returned for evaluation.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.Device implanted.
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Manufacturer Narrative
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An event regarding a fractured device involving an exeter bone plug was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were provided.Device history review: dhr review was satisfactory.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined with the available information.Return of the reported device for evaluation is required to complete the investigation for determining the root cause.A capa trend analysis was conducted for the reported failure mode and concluded that fracture of exeter bone plugs may result from factors such as errors made during use or design factors.No further investigation for this event is possible at this time as the device was not received by stryker orthopaedics.If the device becomes available, this investigation will be reopened.
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Event Description
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It was reported by stryker sales rep that the plugs broke inside a patient's femur during a procedure undergone at (b)(6) hospital.It was confirmed by phone by the sales rep that all three plugs remained inside the patient and will not be able to be returned for evaluation.
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Search Alerts/Recalls
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