SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Overheating of Device (1437); Electrical Shorting (2926)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a hip arthroscopy, the "mdu powermax elite shaver" had a power shortage and the power cord got really hot.The procedure was completed with a delay greater than 30 min using a back-up device.No additional 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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The reported device, used 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 complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Internal complaint reference: case (b)(4).
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with blade stall error and overheating of cord.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.It was determined that the power cord has shorted internal wiring.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.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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