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Model Number RETROVERSION HNDL |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Event Description
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It was reported that during a surgical procedure, when removing a trial stem using the stem extractor, the surgeon accidentally struck the retroversion rod, causing the screw thread to snap off within the stem extractor tool.No fragments, pieces or parts fell into patient wound.Patient was last known to be in stable condition following the event.The device is available for return.
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Manufacturer Narrative
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Based on historical complaint investigations, the returned device, and the reported event, the broken retroversion handle reported was likely the result of the surgeon accidently impacting the retroversion handle while removing a trial stem, leading to ultimate failure of the retroversion handle.
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Search Alerts/Recalls
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