Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed device scratches, but no breakage.The noted damage is consistent with device wear out from heavy usage and the investigation did not establish a need for corrective action.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d9, h6 (medical device problem code).Removed pe code visual: stripped/worn/twisted/cross threaded.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3, h6 (health effect - impact code, health effect - clinical code).
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