Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that during sterilization, one of the ball bearings was identified to be missing from the provisional shim.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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(b)(4).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
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Manufacturer Narrative
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this follow-up report is being submitted to relay additional information.Performed a visual inspection of the returned constrained tibial articular surface provisional shim and found it to exhibit signs of repeated use and have one of two components disassembled / missing.The components were not returned.The device history records and receiving inspection reports were reviewed and researched for deviations and/ or anomalies with no deviations/ anomalies identified.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A complaint history review was conducted.The search identified no other complaints for this device for the same or a similar issue within one year of notification date.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event 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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