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Model Number N/A |
Device Problems
Mechanical Problem (1384); Unstable (1667); Component Missing (2306); Calibration Problem (2890); Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2 : foreign country : (b)(6) product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the device was sent in for preventative maintenance and was found to have several issues including a control bar issue, a calibration issue, a damaged machine head and control bar, a missing hinge sealing, a loose swivel, and had an unstable motor speed.These issues have not endangered any patients or users.Attempts have been made and all available information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Review of the most recent repair record determined the machined head was damaged, the hinge gasket was missing, the swivel was loose, the control bar failed and was out of position, the motor speeds were unstable, and the device was out of calibration: however, the repair was not completed because it is pending materials.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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