Model Number P10.7-80X275 |
Device Problem
Collapse (1099)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any 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 a revision procedure was performed to address a nail that was found to be collapsed, resulting in a loss of distraction.The surgeon believes this may be attributed to full weight bearing and the patient experiencing a fall.
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Manufacturer Narrative
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Visual inspection of the returned nail revealed the housing tube had cracks at the anti-rotation lug or the crown region.Based on the physician report contained within the complaint and the nail condition (broken) there would be no requirement for functional testing or x-ray.The combination of a broken anti-rotation lug and disengaged retention barbs resulted in the loss off distraction.Based on the type of breakage observed and the reported information, the nail broke due to the stress generated from weight bearing activities.Per the precice instructions for use, "the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize external support and/or restrict activities as directed by the physician until consolidation occurs." a review of device history record indicated that the unit was manufactured within the specified requirements at the time and met all of the required quality inspection prior to shipment.
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Event Description
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N/a.
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Search Alerts/Recalls
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