Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Zimmer biomet ribfix blu 12 hole prebent plate catalog #: 76-2602 lot #: unknown and zimmer biomet ribfix blu scr s/d-lk 2.4x8mm catalog #: 76-2408 lot#: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00161 and 0001032347-2022-00163.
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Event Description
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It was reported that a revision was performed due to malposition/loosening of one plate and two screws.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.The root cause of the reported issue is attributed to a user error.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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