DEPUY SYNTHES PRODUCTS LLC KINCISE AUTOMATED SURGICAL IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
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Catalog Number 1000-00-101 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Concomitant med products and therapy dates: impactor devices ((b)(6) 2020).Device manufacture date: the device manufacture date was unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
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Event Description
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This is report 2 of 7 for the same event.It was reported that seven impactor devices were leaking oil.According to the reporter, after sterile processing it was observed that the impactor devices had oil residue on the filters when opened.It was reported that the devices were processed without oiling and there were still leak spots observed.This event did not occur during surgery.There was no patient involvement.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.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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: h4: device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 7/15/2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.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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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: device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device operated as intended except for the observed leaking and excess lubricant found on the battery pack latch hinge pin areas, which was consistent with improper maintenance ¿ not wiping off excess lubricant per manufacturer¿s instructions ¿ user error.It was further determined that the device failed pretest for visual assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to improper maintenance, which is user error.
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