Catalog Number 00223200118 |
Device Problems
Material Frayed (1262); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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Event Description
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It was reported that the product failed in situ and frayed when tightened.The product was removed from the patient.
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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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Reported event was confirmed by review of photos provided.Visual examination of the provided pictures identified the cable is frayed.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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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