Correction: d9/h3, h6 component code.The reported could be confirmed.Photos were provided for investigation and clearly shows the discrepancy in the packaged device and what device should be in the package.A device inspection was not possible since the affected device was not returned, however photos were provided for investigation.The photos confirm that the screws provided for the case were too short for the proximal body to engage with the distal stem.There are two 0mm assembly screws marketed for the tornier hrs system.Catalog # ars655101 corresponds to the screw that is 36.5mm in length.Catalog # ars655118 corresponds to the ¿short¿ screw that is 26.5mm in length.The photos sent clearly show the screw is a ars655118 ¿0mm short screw¿ which will not function properly for this case.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a manufacturing related issue.It was discovered that ars655118 lot az1822082 (quantity (b)(4)) and ars655101 lot az1322077 (quantity (b)(4)) were processed through packaging at the same time.The supplier stated they believe this is a complete swap of lots.They have opened a capa on their end to formalize the root cause and escape.If any additional information is provided, the investigation will be reassessed.H3 other text : device not returned.
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