Model Number 1825-1138S |
Device Problems
Material Fragmentation (1261); Difficult to Remove (1528)
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Patient Problems
Non-union Bone Fracture (2369); Foreign Body In Patient (2687)
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Event Date 03/10/2023 |
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.Device remains implanted in the patient.
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Event Description
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It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".
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Event Description
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It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".
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Manufacturer Narrative
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Correction: please refer to h6 / clinical signs code the reported event could not be confirmed, since the device was not returned and from the available radiographs.A device inspection was not possible since the affected device was not returned and no other evidence were provided for investigation.From the available radiographs, a formal medical opinion was sought: "with the available information, there is no way to determine the reason for the breakage of the instrument.[original statements] a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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Manufacturer Narrative
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Correction: please refer to d3 manufacturer entity.
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Event Description
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It was reported: "when trying to knock out a t2 femur nail, the knockout thread in the nail broke off.Removal of the nail was no longer possible.The customer is currently looking for alternative ways to remove the nail in a next step.".
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Search Alerts/Recalls
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