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Model Number N/A |
Device Problems
Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.
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Event Description
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It was reported that during the operation, it was found that the electric leather cutter was damaged.When the switch handle was powered on, the motor did not vibrate, and the blade did not move.The motor seemed to have been stuck.Hence, another skin graft was taken manually from the patient.There was no delay involved.No additional patient consequences were reported.
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Event Description
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No additional event information.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections have been updated: review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.Per the ifu, the dermatome should be "returned every 12 months for inspection and preventive maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy".
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Search Alerts/Recalls
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