Catalog Number 13200100 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2021 |
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 retained by the hospital.
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Event Description
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During a gamma surgery with a long gamma nail 130 degrees, the drill for the femoral neck screw could not be drilled through the nail.The drill always bumped against the nail.After some time, everything was dismantled and the femoral neck screw was implanted using the freehand technique.
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Event Description
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During a gamma surgery with a long gamma nail 130 degrees, the drill for the femoral neck screw could not be drilled through the nail.The drill always bumped against the nail.After some time, everything was dismantled and the femoral neck screw was implanted using the freehand technique.
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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 no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.According to further details provided ¿the sales rep tested the target device with an implant and everything worked well.¿ and it could not be excluded that the reported event is rather related to a sub-optimal intraoperative procedure.However, the affected nail [implanted] in combination with the counterpart was not made available for evaluation and thus, an exact root cause could not be determined.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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Search Alerts/Recalls
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