SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case- (b)(4).
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Event Description
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It was reported that, during inspection, the mdu was not being recognized.No delay and no applicable back up was available to complete the procedure.No other complications were reported.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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H3,h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with handpiece sensor fault.Cause of fault is a defective electronic component.The complaint was confirmed and the root cause has been determined to be defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
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Event Description
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It was reported that, during labrum inspection, the wand was not being recognized, multiple wands (blades/burrs) were tried to see if that was the problem and it was not.They kept resetting to lower speeds.No delay and no applicable back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Search Alerts/Recalls
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