Catalog Number 110029132 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested from the hospital but was not returned.The investigation is in process.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 while the surgeon was impacting the implant the instrument's tip fractured.Several attempts have been made to obtain additional information.No additional information has been received 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).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the plastic tip of the impactor is broken.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot 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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