Model Number N/A |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/10/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, robotic unit remains at hospital and will be evaluated by engineer.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : robotic unit remains on site.
|
|
Event Description
|
It was reported patient underwent an initial rosa left knee arthroplasty.During the case, rosa gave a constant "force collision error detected" with no force on the arm.Subsequently, case was canceled and patient was woken up from anesthesia.Case was rescheduled.No additional information on the reported event.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated updated: g3; h2; h3; h6.Physical and technical evaluation was performed by a field service engineer (fse), and confirmed the appearance of unknown robotic errors that could not be resolved by multiple restarts.A log inspection discovered a disconnection of the force torque sensor from the arm related to the cable.The fse decided to replace the f/t sensor cable with one from a demo unit, and the errors were resolved.The fse went on to replace the f/t sensor as well and performed an arm accuracy and applicative test to ensure proper function.The unit was fully operational after repairs.Device history record (dhr) was reviewed and no deviations or anomalies were discovered.With the information currently available, a root cause for the malfunction of the force torque sensor and the force sensor cable resulting in disconnections cannot be definitively determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No additional information on the reported event.
|
|
Search Alerts/Recalls
|