DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
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Model Number 1011-01-101 |
Device Problems
Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2022 |
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: concomitant med products and therapy dates: multihole ii cup 54mm (b)(6) 2022).Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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Event Description
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It was reported that during an unspecified surgical procedure it was observed that the impactor device cold welded to the cup device.It was reported that there was no delay in the procedure due to the event.It was reported that a new spare cup device was opened to continue the procedure.There was patient involvement reported.It was reported that all pieces were retrieved.There were no reports of injuries, medical intervention, or prolonged hospitalization.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi - (b)(4) h10 correction: d4, h4: the device serial number was documented as unknown in the initial medwatch report.The serial number (b)(6) has been updated accordingly.The date of manufacture (dom) was documented as unknown in the initial medwatch report.The dom has been corrected to september 5, 2019.The udi has been updated 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and observed that the device failed visual inspection.The cup-adapter was visually and functionally assessed and determined to have thread damage consistent with user error.It was further determined that the device failed pretest for visual assessment, and thread fitting assessment.The assignable root cause of these conditions was determined to be due to improper handling, which is user error.Correction: d9: correction: d9: the date returned to manufacturer was inadvertently documented as december 22, 2022 on the initial report.This date has been updated to december 21, 2022.
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