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Catalog Number 05.001.201 |
Device Problems
Vibration (1674); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.Concomitant med products: lid device, saw blade device.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.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that when using the handpiece device with a saw blade device it was observed that the cover that covers the battery opened due to vibration.It was reported that the device needed to be disassembled and re-adjusted and cover closed to continue cutting.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2021.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 was returned for evaluation.The handpiece device was evaluated and the reported condition that the device had vibration was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the housing of the handpiece device was deformed/bent, there was component damage, and the etching was illegible.It was further determined that the device failed pretest for general condition, marking and labeling, check roundness of the housing, and check fitting of the lid.Therefore, the reported condition that the cover that covers the battery was opening was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.
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Search Alerts/Recalls
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