DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog 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 Type
malfunction
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Event Description
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It was reported that during an unspecified surgical procedure, it was discovered that the impactor device broke where the shaft meets the t-handle.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.Additional narrative: the initial reporter's address was not provided.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: h6: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.
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Search Alerts/Recalls
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