Model Number N/A |
Device Problems
Physical Resistance/Sticking (4012); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that outside of surgery, the device is blocking and freezes while working.There was no patient involvement.Due diligence is complete and there is no additional information available.There is no adverse event associated with this malfunction.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number:(b)(6).G2 country: italy.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the control bar position was not correct and was damaged, the unit was out of calibration, the reciprocation arm and needle bearing were corroded and the motor speed was unstable; however, the repair has not been completed because the repair site is waiting on material for repair.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.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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Event Description
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There is no additional information available regarding the event.
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Search Alerts/Recalls
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