It was reported that three (3) incisor plus bl from the same package were no longer functional after a short time.After the blade was connected to the handpiece it did not work.It is unknown whether the event happened during surgery or if there was patient involvement; however, the procedure was completed with a surgical delay of less than 30 minutes, using a smith and nephew backup device.No further complications were reported.
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H10: (b)(4).H3, h6: the reported devices were received for evaluation.A visual inspection revealed eight devices, three opened and five unopened/sealed, were returned in original packaging with the batch number of the complaint on the label.The five unopened devices had no visible defects in the device or packaging.The three used devices have heavy bio debris present.The teeth on all three blades show wear.Metal flakes are present on all three devices.Scoring is present on all three inner blades.A functional evaluation was performed on the returned devices and found the heavy dried bio debris made separating the inner blades from the outer blades difficult.Hard pieces of bio debris can be felt on all three, when manually turning the blades.Running an unopened blade from the same box/lot, on a reference system, showed it functioned as intended in all modes.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 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 has been associated with unintended use of the device.Factors, which may have contributed to the reported event include: (1) excessive force.(2) tissue thickness.No containment or corrective actions are recommended at this time.
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