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Catalog Number 58-17007E |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Event Description
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As reported: "the surgeon put a variax 2 1.7 cortex screw through a variax hand plate, and saw on the x-ray that the screw looked too long.After removing the screw, it was noticed that it had uncoiled itself and therefore was too long.".
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Manufacturer Narrative
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The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was in used condition.The threads of the screw were chipped of in the thread like form.This generally happens when the screw is screwed without proper alignment with the plate and is in direct contact with the plate edge leading to the chip-off of the threads in such manner.The damaged & deformation of the threads on the screw surface also indicates the same.The device history record could not be reviewed because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was most likely attributed to a user related issue.The failure was caused by mishandling of the device during usage.If any further information is provided, the complaint report will be updated.
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Event Description
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As reported: "the surgeon put a variax 2 1.7 cortex screw through a variax hand plate, and saw on the x-ray that the screw looked too long.After removing the screw, it was noticed that it had uncoiled itself and therefore was too long.".
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Search Alerts/Recalls
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