DEPUY IRELAND UC VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 4515-70-102 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
The device serial or lot number was unknown; therefore, udi: (b)(4).
Unknown.
Device manufacture date is unknown.
The device serial or lot number is unknown.
Concomitant medical devices and therapy dates, robotic assisted satellite station and array set, (b)(6) 2022.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during a total knee arthroscopy procedure and while in the middle of making the femur cuts, the array device "popped" off of the robotic assisted saw handpiece near the blade.
It was reported that the device was also being used with a robotic assisted satellite station.
It was further reported that it was verified the array attached into the saw properly by hearing and feeling it click into place.
It was reported that there were no delays in the surgical procedure.
There was patient involvement.
There were no injuries, medical intervention or prolonged hospitalization.
All available information has been disclosed.
If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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