Model Number N/A |
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 10/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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It was reported that the end of the impactor fractured when it impacted with the floor after the surgeon dropped the impactor.No impact to the patient was reported.Attempts have been made and no additional information is available at this time.
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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 identified a portion of the acetal copolymer subcomponent is fractured and missing.The threaded portion remains in the driver.Field age of the device is 21 years.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It is alleged that the device was dropped; however 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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