Model Number DRILLSAW HIGHSPEED 200 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
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Event Description
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It was reported that during a surgery when attaching to the device two different errors appeared.One that stated that the unit is not recognised and another that there is an error of the unit.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update avoe 19-jun-2023: it was further reported that the failure was noticed before the surgery when connecting the devices shortly before the surgery.A minimally invasive surgery was planned with the reported device.Due to the failure the surgeon had to switch the hallux rigidus procedure by opening the joint to an open surgery.The surgery was finished successfully with different devices (stryker saw and drill).It was not necessary to do a second surgery.Update avoe 19-jun-2023: it was confirmed that the patient was already anesthetized when the error was noticed.
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Manufacturer Narrative
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Event description: it was reported that during a surgery when attaching to the device two different errors appeared.One that stated that the unit is not recognised and another that there is an error of the unit.The reported event was confirmed.The manufacturers evaluation revealed a defective stator of the motor.The device does not recognize the motor which resulted in the reported event.Most likely causes for the observed condition are physical damage to the device, contamination of the motor and/or high temperature form continuous use.
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Search Alerts/Recalls
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