STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 15MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH
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Catalog Number ST015P |
Device Problem
Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Non-union Bone Fracture (2369)
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Event Date 09/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report h3 other text : device remains in patient body.
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Event Description
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Ansm reported that: "patient operated on (b)(6) 2021 for arthrodesis of the 4th left toe, using a smart toe centromedullary implant.Size 15.Subsequently, the arthrodesis did not consolidate.The implant failed.It was therefore necessary to consider to perform a new arthrodesis, remove the implant and use a new toe grip centromedullary implant." "the surgeon operated on the patient on (b)(6) 2023.It was totally impossible to remove the smart toe, even by releasing the proximal close.The 2 phalanges would have had to be "split open".Patient's current condition: arthrodesis had to be performed with another device.Actions taken in the care facility to manage the patient: the surgeon left the smart toe implant in place and performed arthrodesis using 2 crossed pins, one pin positioned above the implant, one pin positioned below the implant.The pins were inserted under scopic control, and the patient had to keep them in place for 6 weeks." (event covered under another complaint stryker ref (b)(4)).
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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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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Ansm reported that: "patient operated on (b)(6) 2021 for arthrodesis of the 4th left toe, using a smart toe centromedullary implant.Size 15.Subsequently, the arthrodesis did not consolidate.The implant failed.It was therefore necessary to consider to perform a new arthrodesis, remove the implant and use a new toe grip centromedullary implant." "the surgeon operated on the patient on (b)(6) 2023.It was totally impossible to remove the smart toe, even by releasing the proximal close.The 2 phalanges would have had to be "split open".Patient's current condition: arthrodesis had to be performed with another device.Actions taken in the care facility to manage the patient: the surgeon left the smart toe implant in place and performed arthrodesis using 2 crossed pins, one pin positioned above the implant, one pin positioned below the implant.The pins were inserted under scopic control, and the patient had to keep them in place for 6 weeks." (event covered under another complaint stryker ref (b)(4)).
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