This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The returned product was visually evaluated, the thumbcam is not locked indicating that the disengagement occurred before step 3 occurred and locked the thumbcam in place.The band has been cut by some type of shear and the locking mechanism was returned, but no plate was returned.The pull release appeared to be fully pulled back allowing for the cam to be released from the tensioner.This likely caused the tensioner to disengage from the locking mechanism.The pull release was likely fully pulled to allow the tensioner to become disengaged from the locking mechanism.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the user not following the steps for use outlined in the instructions for use (ifu).The ifu states: "step 1: push thumb lock up to hold initial tension of the band.Step 2: rotate dial clockwise to fully approximate sternal halves.Note: should tension need to be readjusted during intraoperative placement, rotate dial counter-clockwise to its starting position and push thumb lock down to release tension.Re-approximate by repeating steps 1-2.Step 3: turn the paddle clockwise two full revolutions to lock the device and cut the band." a summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
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