Model Number PS11.5-50B235 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The exact event/explant date is unknown but reported to be in (b)(6) 2021.The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any relevant additional information has been provided, a supplemental report will be submitted.
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Event Description
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Information was received that the nail separated at the junction during an explantation procedure.No patient adverse event was reported.No additional information is available.
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Manufacturer Narrative
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Corrected additional data.
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Event Description
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Additional information was provided.
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Event Description
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No new information was provided.
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Manufacturer Narrative
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Device evaluation: the returned nail was observed and the anti-rotation lug was disengaged from the housing tube which confirmed the reported failure.The barbs of the anti-rotation lug and the anti-rotation feature on the inside of the housing tube had some damage, likely from the disengagement which occurred during the removal of the device.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body.The device was properly manufactured and inspected per the work order.The probable root cause for the disengagement of the anti-rotation lug from the housing body is due the high forces acting on the nail during explantation.It should also be noted that the explantation of the nail was performed after its expiration date.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.
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Search Alerts/Recalls
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