DEPUY SYNTHES PRODUCTS LLC 6.1CM ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
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Catalog Number B-SILVER |
Device Problems
Fluid/Blood Leak (1250); Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Concomitant products: handpiece device, craniotome device, attachment devices, compact speed reducer device.(b)(6).Reporter's phone number was not provided.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.
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Event Description
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This is report 2 of 8 for the same event.It was reported from (b)(6) that the motor device was generating heat and leaking oil while in use with a compact speed reducer device, two craniotome devices, and four attachment devices.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.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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Device was used for treatment, not diagnosis.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearings of the attachment device were damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Additional narrative: it was reported in the initial report that the date returned to manufacturer was september 7, 2018.It was inadvertently reported in the supplemental report that the date returned to manufacturer had been changed to september 6, 2018.Please note that the correct date returned to manufacturer is september 7, 2018, as was originally reported on the initial medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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