Catalog Number 110029132 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Procode: phx.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 the metal impactor head fractured off the handle during an initial procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and 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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No further event information is available at the time of this report.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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Visual examination of the returned product found that the device tips was fractured and the device had signs of repeated use.Sem analysis found that surface artifacts of the fracture site suggest bending overload.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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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