(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length pn: 47235701806 ln: 63550687, 2.7 mm locking screw 14 mm length pn: 47482801402 ln: 63671062, 2.7 mm locking screw 16 mm length pn: 47482801602 ln: 63869781, 2.7 mm locking screw 12 mm length pn: 47482801202 ln: 63861780, 2.7mm locking screw 12mm long pn: unk ln: 62348896, 2.7 mm locking screw 18 mm length pn: 47482801802 ln: 63861772, cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length pn: 47234801835 ln: 63098016, cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688, cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688, cortical bone screw self-tapping hex head 3.5 mm diameter 46 mm length pn: 47234804635 ln: 61214651.Foreign source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00655, 0001822565-2019-00656, 0001822565-2019-00657, 0001822565-2019-00658, 0001822565-2019-00659, 0001822565-2019-00660, 0001822565-2019-00662, 0001822565-2019-00663, 0001822565-2019-00664, 0002648920-2019-00108.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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This follow-up report is being submitted to relay additional information.Following the removal of contamination on the devices, scanning electron microscopy identified isolated pitting corrosion at the screw plate interface constrained to the locking threads of the plate and the screws.The isolated pitting was not identified in other locations of the locking plates and screws, including the discolored areas surrounding the holes from which the tissue deposits were removed.Review of device history record did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The analysis confirms the device and it¿s materials are conforming to specifications.Root cause is unable to be determined at this time.The device labeling states that in-vivo implant corrosion is a possible adverse effect that may be anticipated as the device is implanted in a corrosive environment.Occurrence rates are within the expected rates therefore; no further action is needed at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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