Catalog Number 31301180S |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded by the hospital.
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Event Description
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As reported: "a neck of femur fracture was to be treated with a gamma short nail.During the procedure an issue arose inserting the set screw.Details are unclear but difficulty caused them to remove the set screw and open a spare.Case was then completed without further issues that were raised.".
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Event Description
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As reported: "a neck of femur fracture was to be treated with a gamma short nail.During the procedure an issue arose inserting the set screw.Details are unclear but difficulty caused them to remove the set screw and open a spare.Case was then completed without further issues that were raised.".
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Manufacturer Narrative
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The reported event could be confirmed, although the device was not returned but an image was shared by the customer which confirms the alleged issue.The device was not returned for evaluation but an image of it was shared by the customer which shows signs of misalignment evident by deformed and flattened threads.The deformation mark around the tip region where the transition (square to taper) starts also indicates the same, as under proper insertion this area cannot get deformed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based only on the available information and the image, the issue is deemed to be user related.There are signs of misalignment observed in the set screw which most likely led to inadequate insertion of it during the surgery.If any further information is provided, the complaint report will be updated.
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Search Alerts/Recalls
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