(b)(4).Additional concomitant medical products: headless trocar drill pin 3.2 mm diameter 75 mm length, catalog #: 00590102000, lot #: unknown.Complaint sample was evaluated and the reported event was confirmed.Visual inspection was performed on the returned guide, it was noted that a portion of a trocar drill pin is seized in one of the guide holes of the tibia cut guide.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|