Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00550.
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Event Description
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It was reported that during a right hip procedure the shell got stuck on the inserter handle, and surgeon could not separate them.Another handle and shell were used to complete the case.There was no consequences or impact to the patient.No additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual examination of the returned product identified that the shell and inserter were disassembled upon receipt.The inserter shaft was scratched.The threads of the inserter were free of significant damage.Dark debris was present within the threads.The shell exhibited similar debris within the threads.No thread damage was observed on the shell.During evaluation, the shell was able to be threaded onto and off of the inserter multiple times.The shell fully engages the inserter threads.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.No device problem was found.The devices function as intended.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 is available at the time of this report.
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Search Alerts/Recalls
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