Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Overheating of Device (1437); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2023 |
Event Type
malfunction
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Event Description
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It was reported the handpiece(electric dermatome) does not work properly, accompanied with hot before the surgery.No patient involved.There was charring on the surface of the defective motor, and there was no harm to the operator.No further information is available at this time as diligence is complete.
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device was not working properly; charring on the motor.The motor, bearings, and various screws were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further information is available at this time.
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Search Alerts/Recalls
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