DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
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Model Number 1011-01-101 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2022 |
Event Type
malfunction
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Event Description
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This is report 1 of 2 for the same event.It was reported that during an unspecified surgical procedure it was observed that two cup adapter devices broke at the t-handle junction.It was reported that there was no delay in the procedure due to the event.It was not reported if there was a spare device available for use.It was reported that all pieces were retrieved from the patient.There was patient involvement reported.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.As of this date, the device has not been returned for evaluation.Therefore; the reported condition cannot be confirmed and/or duplicated.Udi ¿ (b)(4).
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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 the reported condition that the device broke at the t-handle junction was confirmed.An assessment was performed, and it was determined that the device failed visual inspection.During the assessment of the device, it was observed the device had a broken t-handle consistent with having been dropped or other radial (off-axis) force.It was further determined that the device failed pretest for visual assessment, end cap thread assessment, and keyless fitting assessment.It was determined that the most probable cause for the found defect is improper handling by the user.The assignable root cause of this condition was determined to be traced to user, which is user error.
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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: b5: upon subsequent follow-up with the customer, additional information was received.The reporter stated that the device had a broken screw t-handle.
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