Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported that during setup for a knee procedure the impactor disassembled with a string detaching from the device.No adverse events have been reported as a result of the malfunction.
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Event Description
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under manufacturing report number 0001825034-2022-01815.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under manufacturing report number 0001825034-2022-01815.
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Search Alerts/Recalls
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