Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that, after implantation of the trial implant the front part of the advanced applicator outer shaft broke off.No fragments were generated.The trial implant was removed.The outer shaft and inner part of the trial implant can no longer be removed.Additionally, two (2) advanced applicator inner shafts broke off at the rear end in the taper ball connection area.Another set of instruments was available to use.Procedure was completed successfully.There was no patient consequence reported.This report is for one (1) advanced appl inner shaft.This is report 4 of 4 for (b)(4).
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