Model Number 130720101 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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 the size 1 center epi did not fit into the unite stem.No delays as a second implant was opened and fit perfectly.
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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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device cannot confirmed the reported event.There was no quality issue identified with the dxtend mod cent epi 1 ha.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a review was completed of the device history record (dhr) and operations management system (oms).Delta xtend epi ha body (wo (b)(4)): product code 130720101, work order (b)(4) was manufactured on 02-apr-2021.All raw materials met specification.(b)(4) parts were manufactured to specification.Scrap: o (b)(4) parts from this lot was scrapped: o scrap code a1095: this concerns epi ctq 3 ¿ surface finish.There is no correlation between this scrap reason and the failure mode of the complaint.Non conformances: there is no correlation on any non conformance related to this reported complaint.
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Search Alerts/Recalls
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