Catalog Number 00430904100 |
Device Problem
Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been 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: 0001822565 - 2022 - 00116, 0001822565 - 2022 - 00345, 0001822565 - 2022 - 00346.
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Event Description
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It was reported that the baseplate reamers are dull and unusable.These were identified outside of surgery.No additional information is available at this time.
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Event Description
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No additional information is 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 additional information.Visual examination of the returned product identified lots 62364024, 63495268 , 64124856 , 64124856.All devices exhibit signs of use (nicked or gouged) and all the blades are dull.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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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