SMITH & NEPHEW, INC. HUMERAL NAIL IMPACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 71751133 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/18/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery on tightening, the head of the impactor just fell off which complicated the case.A backup device was available.More than 30 minutes delay was reported.
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Manufacturer Narrative
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The associated complaint devices were not returned.A review of the provided pictures of the drop and driver confirmed the stated failure.The drop was missing the tightening screw and the strike plate on the driver fractured off at the weld joint.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re opened.
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