Model Number 1832-3824S |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Failure of Implant (1924); Limb Fracture (4518)
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Event Date 04/08/2021 |
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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The surgeon reported that none of the instruments on the metal extraction fit the proximal humeral nail.He reported that he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.As a result, the proximal humerus was split to loosen the nail.There was a 75 minute surgical delay as a result of the event.
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Event Description
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The surgeon reported that none of the instruments on the metal extraction fit the proximal humeral nail.He reported that he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.As a result, the proximal humerus was split to loosen the nail.There was a 75 minute surgical delay as a result of the event.
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Manufacturer Narrative
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H6 correction to clinical sign code.The reported event could not be confirmed, since the device was not returned for evaluation and thus, evaluation limited to details available.Due to missing nail a physical inspection of the implant in question was impossible.Returned counterparts were checked for functionality with a sample nail and revealed to be functional as intended.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.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.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.
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Search Alerts/Recalls
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