SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2020 |
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 a shoulder case surgery the motor drive unit was not being read.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.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, used 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 the blade id test.Cause of test failure is a defective electronic component on the hall board.The complaint was confirmed and the root cause has been determined to be a 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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Search Alerts/Recalls
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