Catalog Number UNK_KIE |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Bone Fracture(s) (1870); Pain (1994)
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Event Date 02/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
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Event Description
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The surgeon reported that the patient presented with pain and arthritis in the hip and because of this he undertook revision surgery for removal of a long gamma nail and conversion to a tha.Removal of the nail was a pre-requisite for the tha.The gamma nail had been implanted in approximately 2013.When the patient was opened the surgeon noticed that the most proximal of 2 distal screws was broken.The broken screw had been asymptomatic.The surgeon removed part of the screw, leaving the remaining piece of the screw in the bone.The surgeon did not attempt to remove the remaining piece of the screw.While taking the nail out, the surgeon struggled and tapped the nail.It is unclear whether the remaining screw was catching as the nail was removed.As the nail was removed, the patient sustained stress riser fracture which required an additional plating procedure.This plating resulted in a 2 hour surgical delay.The total delay to surgery was 2.5 hours.The tha was completed.
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Event Description
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The surgeon reported that the patient presented with pain and arthritis in the hip and because of this he undertook revision surgery for removal of a long gamma nail and conversion to a tha.Removal of the nail was a pre-requisite for the tha.The gamma nail had been implanted in approximately 2013.When the patient was opened the surgeon noticed that the most proximal of 2 distal screws was broken.The broken screw had been asymptomatic.The surgeon removed part of the screw, leaving the remaining piece of the screw in the bone.The surgeon did not attempt to remove the remaining piece of the screw.While taking the nail out, the surgeon struggled and tapped the nail.It is unclear whether the remaining screw was catching as the nail was removed.As the nail was removed, the patient sustained stress riser fracture which required an additional plating procedure.This plating resulted in a 2 hour surgical delay.The total delay to surgery was 2.5 hours.The tha was completed.
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Manufacturer Narrative
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Correction: refer to h6 device code.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
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Search Alerts/Recalls
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