(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03172, 0001825034-2020-03173, 0001825034-2020-03175, 0001825034-2020-03176.Concomitant medical devices: part# 912082; lot# 003010, part# 912082; lot# 071710, part# 912082; lot# 554580, part# 912082; lot# 725310.Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported approximately four (4) weeks ago during surgery, the clear sleeve of the juggerknot mini would not move.The surgeon tried using five (5) different juggerknot minis of the same model, all which had this problem.There was a surgical delay for an unknown amount of time.Attempts have been made and no further information has been provided.
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