SMITH & NEPHEW, INC. ACCORD DUAL ENDED HEX DRIVER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71360046 |
Device Problems
Connection Problem (2900); Material Deformation (2976); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a hip surgery, two (2) accord dual ended hex driver, were worn and did not lock properly with the screw head.It is unknown how the surgery was completed, and if there was any significant delay.Patient was not impacted by this event.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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