Event: after the process of pre-washing and sterilized the product (drill) were oxidized.Details of the event: the new products entered yesterday ((b)(6) 2018) to the (b)(6), which were washed and brushed by hand one by one inside and outside, with 10 minutes of submerged.This process was done 3 times yesterday.Today they were steam sterilized and when they came out they had spots of drops.They were submerged again with enzymatic for 10 minutes and when went back, they were brushed one by one and with a sponge and all the spots were removed.After this, they was put in the process of washing and drying machine and finished this cycle , it was identified that those have the small laser letter were oxidized.I detail below the list of code and lot of them, are 25 in total: product information: (b)(4).As the product complaint has several products (ip), we registered 2 complaints ((b)(4)).(b)(4).
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Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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