SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2021 |
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, the motor drive unit buttons were faulty, one of the buttons does not respond.No case reported; therefore, there was no patient involvement.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 reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no issues were noted.Complaint of button malfunction was confirmed.Product failed functional testing when the left and middle buttons failed to function.Cause of button malfunction is corroded button magnets that were severely corroded.Both buttons perform as expected with a known good magnet installed.The complaint was verified and the root cause is corrosion of button assemblies.Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time.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.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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