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Catalog Number 05.001.201 |
Device Problems
Device Reprocessing Problem (1091); Leak/Splash (1354); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Event Description
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It was reported from (b)(6) that the battery handpiece device had water coming out of the motor and made a strange noise.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.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 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.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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the battery handpiece device made a strange noise was not confirmed.Therefore, an assignable root cause for this condition was not determined.However, during evaluation, it was determined that the device had a leak tightness test failure, moving parts did not move smoothly and the device would not run.It was further determined that the device failed pretest for leakage test using bubble emission technique, check for mechanical free moving and check function of device.Therefore, the reported condition that the device had water leaking from the motor was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.
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Search Alerts/Recalls
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