Catalog Number 03829535 |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/14/2014 |
Event Type
malfunction
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Event Description
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It was reported that during routine scoliosis surgery, due to misplacing the screwdriver on the screw by the nurse, surgeon tried to implant and forced the screw in that condition without knowing that it is misplaced which resulted in deformation and partial breakage on the screwdriver and deformation of the screw.However the surgery is completed with other screw and screwdriver which is in the kit.No adverse event has happened and no delay occurred in the surgery.
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Manufacturer Narrative
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Correction: the device did not contribute to the customer reported event and is a concomitant product.Xia screw did not malfunction, xia screw driver did: mdr mfg reference #0009617544-2014-00106.
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Event Description
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It was reported that during routine scollosis surgery, due to misplacing the screwdriver on the screw by the nurse, surgeon tried to implant and forced the screw in that condition without knowing that it is misplaced which resulted in deformation and partial breakage on the screwdriver and deformation of the screw.However the surgery is completed with other screw and screwdriver which is in the kit.No adverse event has happened and no delay occurred in the surgery.
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Search Alerts/Recalls
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