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 12/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that the motor drive unit had a bad button.It is unknown whether the event happened during surgery and if there was a patient involvement.No further information was available.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, 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 functional testing with button malfunction.Middle button would not activate motor.Cause of button malfunction is a corroded button assembly.The complaint was confirmed and the root cause has been determined to be corrosion of the button assembly.Factors which can contribute to button corrosion include cleaning and sterilization methods and the chemicals involved.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.No containment or corrective actions are recommended at this time.
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Manufacturer Narrative
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H10: h2: additional information on b5.
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Event Description
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It was reported that.During a knee a surgery and internal to the patient, the motor drive unit was noticed to have a bad button.The procedure was completed without delay using a back-up device.No patient injury or 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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