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Catalog Number UNKN02000000 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, the distal screw in the tibial nail was cut due to lack of proper size.No further information was provided regarding any procedure complications, delay nor patient outcome.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Additional information was received that identified this event should be re-evaluated for mdr reporting.The new information states that this was an inquiry from the physician as to whether screws could be cut to the required size, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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