Model Number 14-440321 |
Device Problems
Fracture (1260); Patient Device Interaction Problem (4001)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930)
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Event Date 03/29/2022 |
Event Type
Injury
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Event Description
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The patient underwent phoenix nail implantation due to an infection in the ankle area.During the regular inspection, it was reported that the nail was broken at the screw hole.Hence, a revision procedure was performed where the surgeon found infection again in the patient.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Foreign: (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause for the fracture of the implant was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.H3 other text : device has been discarded.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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