Model Number PS11.5-80B265 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device evaluation is in progress; upon completion, a follow-up medwatch will be submitted.
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Event Description
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It was reported that upon removal of the nail after it had achieved its intended purpose and outcome, it was noted that there were changes to the metal on the distal screw hole at the junction of the nail.No patient impact or adverse event was reported.
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Manufacturer Narrative
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Device records review: a review of dhr for the returned unit confirmed that it met all the required quality inspection criteria prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had corrosion.The root cause cannot be determined at this time; further investigation is being conducted through the capa process.
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Event Description
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No additional event information was provided.
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Search Alerts/Recalls
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