Model Number 3425-1300S |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Failure of Implant (1924); Implant Pain (4561)
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Event Date 01/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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It was reported that after an hour and a quarter surgical osteosynthesis of the right femur with intramedullary nail due to a right femoral per-sub trochanteric fracture, the x-ray finding of the rupture of the device with the need for hospitalization and revision surgery.
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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It was reported that after an hour and a quarter surgical osteosynthesis of the right femur with intramedullary nail due to a right femoral per-sub trochanteric fracture, the x-ray finding of the rupture of the device with the need for hospitalization and revision surgery.
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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.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 after an hour and a quarter surgical osteosynthesis of the right femur with intramedullary nail due to a right femoral per-sub trochanteric fracture, the x-ray finding of the rupture of the device with the need for hospitalization and revision surgery.
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Search Alerts/Recalls
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