Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: catalog#:: 912082, jgrknt 1.0mm mini 3- 0 ndls, lot#: 0002446043.Report source: japan.Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00569.
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Event Description
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It was reported that during the surgery, the tip of inserter was fractured during use.The same incident occurred with 2 products.Fortunately, the fractured pieces of the inserters were removed, so nothing remains in the patient's body.There is no further information at this time.
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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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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be 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.
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Search Alerts/Recalls
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