Correction: d1, d2a, d2b, d4 (catalog#, lot#), gtin, g1, g4 (510(k)), h3, h6 (method code).The reported non-union can be confirmed based on the provided operation report of the revision surgery.The device inspection revealed the following: one (1) plate together with seven (7) screws was returned for evaluation.The plate is broken apart and does belong to the legacy stryker variax 2 foot system.Three (3) of the returned screws belong to the variax 2 system.The other four (4) screw belong most likely to the legacy wright medical cannulated screw system (css).The evaluation of these devices will be performed under the complaints 3216512, 3216513, 3223765 and 3223766.The visual inspection has shown that the returned 16mm variax locking screw is in a used condition, the head and as well the thread flanks have clearly visible wear marks.Also the locking thread is slightly worn, which indicates that the screw was locked in the plate as required.Afterwards it cannot be defined anymore if these damages occurred during implantation, in-situ or during extraction.Otherwise is the screw in a good condition and there is no indication that any issue at the screw did contribute to the reported non-union.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.No product related issue could be detected.There was no additional information about the event provided, it is unknown how long the implants were implanted, no x-rays and no information about the patient history/activity was provided.In addition, it is unknown how the returned implants from different systems are related to each other.Therefore the root cause of the reported non-union cannot be defined.During the investigation no indication could be detected that the returned screws did contribute to the reported non-union and there was no allegation against the screws, e.G.Loosening, reported.These findings speak against a screw related issue.If more information is provided, the case will be reassessed.
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