Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42509901000, 0 degree distal cut block, 02500936.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2021-02107.
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Event Description
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It was reported that the 3.2 headless trochar pin cold welded into the distal femoral cut block.The rep was unable to get the pin out of the jig.There was no surgical delay.The surgical technique was utilized.The surgery was completed with a second device.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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