Model Number N/A |
Device Problems
Fracture (1260); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the device fractured.The plastic part was broken off at the threads and the handle with the threaded part of the plastic piece was stuck in it.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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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.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device signs of repeated use and has fractured off in component.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use.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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