A review of the device history record revealed no complaint regarding related anomalies.The dhr shows this lot of proximal humeral plate 4-hole as well as the locking screws were processed through normal manufacturing and inspection operations with no non-conformances or rework noted.The product lots met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.In addition, we have inspected the returned device and made a material analysis as well as a dimensional check and no deviation was detected.The plate holes were inspected with an electronic magnifier and the top of the plate holes have only slight grooves, indicating that the screws were not fully locked with the plate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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