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Correction: g1 (reporting contact), g4 (pma/510k), h3 (device evaluation status).The reported event was rated as confirmed due to the observed damages at the received devices.The device inspection revealed the following: the distal medial femur plate was returned for evaluation.Several damages could be observed at the universal holes.Two (2) of the distal universal holes are more severely damaged and it is likely that a proper screw locking function was not given anymore in those holes.Based on this is the complaint rated as confirmed although no x-rays or any other evidence was provided, which would confirm the occurrence.Two (2) holes have damaged edges, which indicates a an out of the 30° cone contact.All other holes of the plate, are either intact as no screw was inserted or have the typical damages that occur when locking screw or a cortex screw is correctly inserted.The anodized layer is not present anymore at all observed damages, which indicates that the damages were caused post manufacturing.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 reviewed by rnd, including a interview with the operating physician, with following result: "1.Although the plate contains 13 possible screw holes, microscopic examination indicates that only 5 screws were actually used.2.The two holes (1 and 3) in which cortical screws appear to have been placed show normal contact marks consistent with proper screw engagement.3.Three holes (10, 12, and 13) show traces characteristic of locking screws.4.Hole 12 presents normal locking-screw imprints along its edges, whereas holes 10 and 13 show significant edge damage.5.A mechanical failure involving the entire distal portion¿where the three locking screws were used¿would typically produce similar edge wear in all three holes (assuming a non-comminuted fracture).The severe edge wear observed in hole 13 contrasts markedly with the more regular imprint pattern seen in adjacent hole 12.Multiple explanations are possible.Without patient x-rays, fracture pattern information, or knowledge of how many plates were used for this indication, we cannot determine: - whether the low number of screws used was appropriate; -whether screws were targeting individual fragments; - whether the heavy wear in hole 13 is related to: 1.An initial mechanical failure causing a loosened screw to bear weight 2.Accidental hardware contact (e.G., from a drill), or 3.An attempt to lock the screw beyond 15°, causing the screw to spin and ream the hole edges.The substantial edge wear observed in holes 10 and 13 indicates locking-mechanism failure.However, based on the available samples, no single cause for this failure can be definitively identified." no product related issue could be detected during the investigation.Based on the provided information, no pre-, intra- and post-operative x-rays in different planes, operation reports, detailed patient details, history and activity was provided, the root cause of the reported event cannot be defined.There are too many factors, like screw insertion angle and torque, position of other already present implants, fracture situation, patient condition, especially in relation to bone quality and activity, that could have played a role.If more information is provided, the case will be reassessed.
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