Model Number 2975-00-635 |
Device Problems
Loose or Intermittent Connection (1371); Structural Problem (2506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2020 |
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 when trying to lock the distal stem onto the bottom of the distal stem insertion handle, the handle provides rotational freedom of the distal stem on the end of the insertion handle.This has occurred multiple times with the same handle.When trying to engage the taper with the assembly tool, the helicopter handle continued to spin and never broke the tensile bar to guarantee engagement of the taper.This has occurred multiple times with the same assembly tool.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned instrument partially 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.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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