Model Number N/A |
Device Problems
Unstable (1667); Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Laceration(s) (1946)
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Event Date 06/28/2023 |
Event Type
Injury
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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: canada.
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Event Description
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It was reported that during surgery, the device skips a section when used.An additional graft was needed, and another device was utilized to complete the surgery.There was a 20-minute delay in the procedure where the patient was under anesthesia.There was no note of patient harm.Due diligence is complete and there is no additional information available.
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Event Description
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There is no additional information available regarding the event.
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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 motor speeds were noisy/shaky and the device was out of calibration; spring seal and retaining ring were not seated properly.The spring seal, retaining ring, fine adjustment cams, and bearings were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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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Search Alerts/Recalls
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