Model Number 110024773 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign- japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was has been discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
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Event Description
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It was reported that during the surgery, the anchor didn't be pushed out although the surgeon forwarded the black button on the complaint device.There was a surgical delay of approximately fifteen minutes to prepare an alternate product.No adverse event has been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
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Event Description
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No further event information is 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
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Search Alerts/Recalls
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