Catalog Number 110028879 |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Fda product code - phx.Foreign - event occurred in (b)(6).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.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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It was reported that approximately two (2) weeks ago, the tip of the impactor broke during surgery with the final impact of the implant.No pieces fell into the patient.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.Visual examination of the provided pictures identified the instrument fracture.Product not returned.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.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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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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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified end cap was received broken into 2 pieces.Dents and dings on strike plate.Some discoloration in the threads of the end cap.The root cause of the previous investigation does not change based on the additional information received.If any further information 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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Search Alerts/Recalls
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