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Catalog Number 05.001.084 |
Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the date of manufacture was unknown.D10: concomitant device: air hose device, therapy date: (b)(6) 2023.Udi: (b)(4).
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Event Description
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This is device 1 of 2 from the same event.It was reported from colombia that at the beginning of an unspecified surgical procedure, it was observed that the double air hose device "is triggered".During further follow up with the reporter it was clarified that the hose was exploding.The first spare device exploded too.A second spare device was used to complete the procedure successfully.There was a five minute delay in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A1, b3: patient initials and date of event have been added.D10: therapy date: (b)(6) 2023.
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Search Alerts/Recalls
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