Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign.The event occurred in (b)(6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the reamer chipped during use.Attempts have been made and no further information is available at this time.
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Manufacturer Narrative
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(b)(4).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 the reamer chipped during use and a fragment remained in patient attempts have been made and no further information is available at this time.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual inspection was performed on the screw and confirmed the tip fractured.Also noted the damage on the flutes, scratches on the shaft, and near the quick connect.The cutting edges were dull and worn with multiple nicks indicative of use.Wear on the flutes leads to the dullness of the cutting edges thereby increasing the force on the instrument when operating, which can cause fracture.The returned instrument was sent to sem for fracture analysis and it was noted that the instrument fractured due to overload.Device history record was reviewed and no discrepancies were found.The root cause can be determined as wear and tear from 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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Search Alerts/Recalls
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