Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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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 an instrument was returned via worn instrument return program, and was found to be missing a ball bearing.There was no reported patient involvement.
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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 corrected and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned tasp identified the device exhibits signs of repeated use (nicked or gouged) and has a ball bearing missing.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a previously addressed design issue.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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