Catalog Number 00234712315 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source - foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00170.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.Product not returned.
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Event Description
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It was reported that the length of the screws are not consistent with the labeling.There was no 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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Complaint sample was evaluated and the reported event was confirmed.Visual inspection and dimensional analysis of the returned products confirmed the screws are shorter than the actual length confirming the complaint.Device history record was reviewed and no discrepancies relevant to the reported event were found.The operator is considered a contributory factor for the reported event as the operators failed to detect the non-conformity.However, a definitive cause that triggered the smaller screw non-conformance during manufacturing could not be determined.The complaint is being reviewed through the capa process to determine what further actions are necessary.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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