Model Number 06030813 |
Device Problems
Fracture (1260); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/22/2015 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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During insertion of the femoral trial, dr.Used a mallet to strike the 111140 inserter/extractor and the threaded tip broke off inside the trial.No issues arose from this incident as dr.Was able to remove the trial by hand.I advised him that the instrument was not intended for impaction with a mallet as we provide a separate impactor in the tray.
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Manufacturer Narrative
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An event regarding fracture of a femoral trial slaphammer was reported.The event was not confirmed.Method & results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other events for the lot referenced.Conclusion: the event could not be confirmed but based on the provided information, the root cause was likely due to user error as the femoral trial is intended to be impacted, not the reported slaphammer.No further investigation is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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During insertion of the femoral trial, dr.Used a mallet to strike the 111140 inserter/extractor and the threaded tip broke off inside the trial.No issues arose from this incident as dr.Was able to remove the trial by hand.I advised him that the instrument was not intended for impaction with a mallet as we provide a separate impactor in the tray.
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Search Alerts/Recalls
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