Catalog Number 244000557 |
Device Problems
Crack (1135); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that as per hospital, they feel some of the reamers are cracked.I was not sure if it is just wear and tear from being used so i would like j&j to look over and send report back on their findings.If there is an issue, then will the hospital credit new ones replaced at no charge? there are 4 of the graters that i can not read the lot number.No surgical delay.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
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Manufacturer Narrative
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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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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