Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.The root cause is attributed to heavy usage and wear out.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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Surgeons are starting to complain that the poly tips on the head impactors are worn out and should be replaced.All question of normal wear, doing more than 400 hips a year.No patient damage, but want them to be exchanged before they cause damage.No delays in surgeries.Just a case of normal wear.Pls replace asap (b)(6).Patient consequence? :no.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 product complaint # = > (b)(4).Investigation summary = > examination of the returned instrument confirmed the reported observation.The root cause is attributed to heavy usage and wear out.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.Device history lot = > null device history batch = > null device history review = > null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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