Catalog Number 35250300S |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Code Available (3191)
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Event Date 04/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
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Event Description
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It was reported that the operator incorrectly implanted the left gamma nail on right foot.A condition in which nail penetrate the anterior cortex of the supracondylar region.The operation was finished, because the patient was elderly.Whether replacement surgery will be performed is undecided.Nail was penetrate the cortical bone of the supracondylar region.Because the left nail was inserted into the right affected area.
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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 evidences were provided.The device inspection was not possible as the product was not returned for investigation.However the event description itself describes that ¿the operator incorrectly implanted the left gamma nail on right foot¿.Thus, it is clear that the alleged event is not a result of any deficiency in the product but rather user related i.E.Hcp using device in off-label manner and not as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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It was reported that the operator incorrectly implanted the left gamma nail on right foot.A condition in which nail penetrate the anterior cortex of the supracondylar region.The operation was finished, because the patient was elderly.Whether replacement surgery will be performed is undecided.Nail was penetrate the cortical bone of the supracondylar region.Because the left nail was inserted into the right affected area.
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Search Alerts/Recalls
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