SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).
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Event Description
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It was reported that there were metal shavings coming out of the motor drive unit.No case was reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed the mdu worked as intended.No issues were found.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include wear and tear from cleaning and sterilization methods and the chemicals involved over a period of time.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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