STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 2353-3103 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
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Event Description
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It was reported: "patient had an in situ femoral gt alpha nail, placed at (b)(6) hospital about two weeks ago for a second stage revision due to infection.Exchange nail today intended for definitive fixation.Patient on lateral position.After the removal of the in situ nail, ream as normal.Checked nail alignment before introducing.Hydroset placed on femoral head and neck.Nail covered on antibiotics paste.Nail introduced on femoral canal.Inferior wire placed, satisfactory ap and lateral x-ray views.Drilling of superior sleeve on ap view, recon lag screw placement satisfactory on ap view, however, lateral x-ray view confirmed screw was posterior to the nail.Re attempt to drill no satisfactory, going posterior to the nail again.Drilled the inferior hole satisfactory on both ap and lateral x-ray views.Recon lag screw placement satisfactory in both views.Re attempt to drill again superior hole, now with the inferior hole having the screw through, again missed, posterior to the nail.Decided to proceed to distal locking and only one recon lag screw was placed".
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and thus, limited to details available.According to event description the device in question was tested pre-surgical and also post-surgical.During both, simulation of pre-surgical function check and also after the procedure, the device in question was found to be fully functional, which was confirmed by the customer.Based on above facts the case is rather related to a sub-optimal intraoperative procedure and has to be classified as user related.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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Event Description
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It was reported: "patient had an in situ femoral gt alpha nail, placed at st marys hospital about two weeks ago for a second stage revision due to infection.Exchange nail today intended for definitive fixation.Patient on lateral position.After the removal of the in situ nail, ream as normal.Checked nail alignment before introducing.Hydroset placed on femoral head and neck.Nail covered on antibiotics paste.Nail introduced on femoral canal.Inferior wire placed, satisfactory ap and lateral x-ray views.Drilling of superior sleeve on ap view, recon lag screw placement satisfactory on ap view, however, lateral x-ray view confirmed screw was posterior to the nail.Re attempt to drill no satisfactory, going posterior to the nail again.Drilled the inferior hole satisfactory on both ap and lateral x-ray views.Recon lag screw placement satisfactory in both views.Re attempt to drill again superior hole, now with the inferior hole having the screw through, again missed, posterior to the nail.Decided to proceed to distal locking and only one recon lag screw was placed".
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