Model Number 1246-03-000 |
Device Problems
Difficult to Insert (1316); Device Dislodged or Dislocated (2923)
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Patient Problems
Not Applicable (3189); Insufficient Information (4580)
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Event Date 07/30/2019 |
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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Intraoperatively the apex hole eliminator spinned through the already implanted pinnacle cup.The pinnacle cup was removed and hole eliminator was retrieved.(same) cup was inserted again.Surgery prolongation of about 10 minutes was reported.
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Manufacturer Narrative
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Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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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.Product complaint # (b)(4).The apex hole eliminator was returned for investigation and found to conform to drawing requirements with the exception of thread damage which would not have passed through visual inspection and is thus deemed to be as a cause of assembly / disassembly by the surgeon from the above, the reported complaint can not be confirmed by suzhou.And the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.The product shall be retained in secure location for future reference unless specifically requested to be returned by the complainant.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 : 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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Manufacturer Narrative
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Product complaint # (b)(4).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. added: d10.Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the apex hole eliminator was returned for investigation and found to conform to drawing requirements with the exception of thread damage which would not have passed through visual inspection and is thus deemed to be as a cause of assembly / disassembly by the surgeon from the above, the reported complaint can not be confirmed by suzhou.And the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.The product shall be retained in secure location for future reference unless specifically requested to be returned by the complainant.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.
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Search Alerts/Recalls
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