SMITH & NEPHEW, INC. SEMIEXTENDED DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71654524 |
Device Problems
Connection Problem (2900); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It was reported that during procedure was difficult to the surgeon to connect the three prongs of the semiextended drill guide to the holes in meta anterior drop.Had to use quite a bit of force in order to connect it.There was a delay of less than 30 min.Procedure concluded with the same devices.After procedure, it was noticed metal tips of the drill bent causing the drop getting damaged as well.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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The information received by the manufacturer has been re-evaluated for mdr reporting and 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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