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Catalog Number 05.001.201 |
Device Problems
Mechanical Problem (1384); Vibration (1674); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the motor cover of the battery handpiece device did not lock properly and when used in saw mode, the vibrations caused the cover to come loose and the non-sterile battery to fall into the surgical field.It was reported that there were delays to the surgical procedure.It was not reported 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 unknown.However, it was reported that the event occurred in (b)(6) of 2022.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.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: 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: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device had a locking issue and lid failure.It was further determined that the housing showed additional marking and general signed of wear.It was further determined that the device failed pretest for general condition, marking and labeling, leakage test using bubble emission technique, and checking roundness of housing.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to the user, which is user error.
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Search Alerts/Recalls
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