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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 12/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the impactor broke during impaction.All pieces were recovered.There was no consequences or impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. visual examination of the provided pictures identified the impactor pad broke in half.No further evaluation can be made from the provided pictures.Lot identification is necessary for review of device history records, lot identification was not provided.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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