It was reported that the proximal lateral tibia plate and screws were broken.Due to an acute infection, the broken implants, a medial plate and additional screws, were removed and resolved with temporary external fixation placement.
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The reported event could be confirmed, since the plate is broken as complained.The device inspection revealed the following: the visual inspection has shown that the screw is broken apart at the threaded shaft, the shaft fragment of about 27.7mm length was not returned for evaluation.The microscopic inspection has shown that more than half of the fracture face is not visible anymore, the shiny surface indicates that the fracture faces did rub against each other for a longer period of time.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.The relevant dimensions were as far as possible checked and no deviation from the specification could be detected.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.The complaint was forwarded to medical affairs for a medical opinion with following feedback: "it is obvious, that the non-union led to the failure of the plate.The plate broke with loosening of the screws due to the continuous high loads following the non-union.The underlying cause remains a little unclear.Probably it is patient related factors.The patient smokes cigarettes with a high rate (because that makes the early onset of lung cancer more likely) and this makes vessel damage and arteriosclerosis and reduced metabolism at the fracture site more likely.If there is other therapies (e.G.Chemotherapy) present it could also reduce the bone union.The surgeons took the complex fracture into account and performed both a lateral and an anteromedial osteosynthesis.Conclusively the mixture of the complex fracture patterns and potentially other patient related factors may have contributed to the failure of the device." based on investigation, the root cause of the breakage was attributed to a patient related issue.Different patient related factors did result in an non-union of the complex fracture followed by fatigue failure of the screw in this area.Related to the mentioned infection, it can be confirmed that the device in question was supplied in unsterile condition to the customer.In this relation following statement from the instructions for use can be pointed out: ¿warning in the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.¿ if more information is provided, the case will be reassessed.
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It was reported that the proximal lateral tibia plate and screws were broken.Due to an acute infection, the broken implants, a medial plate and additional screws, were removed and resolved with temporary external fixation placement.
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