Model Number N/A |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 that while using a targeting guide one of the drilled holes was out of alignment.Surgeon had to drill new hole manually.No additional information is available.No adverse event was reported.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual inspection of the returned device identified damage on the target guide handle.The device shows wear & tear that indicates repeated use during a potential field age of approximately 8 years 5 months.If any further information is found 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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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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