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Model Number EMAX2PLUS |
Device Problems
Component Missing (2306); Excessive Heating (4030)
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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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Event Description
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It was reported from (b)(6) that the motor device was missing a housing pin and the device¿s knob part became hot.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.The exact date of the event was unknown.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 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.The reporter¿s complete facility address and phone number were not provided.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.(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: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the initial reported condition that the knob on the device became hot was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition that the device housing pin was missing was confirmed.The assignable root cause was determined to be traced to component failure from wear.
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Search Alerts/Recalls
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