(b)(4).D10 - associated medical devices: oxf twin-peg cmntd fem sm pma; item# 161468; lot# 332200.Oxf anat brg rt sm size 3 pma; item# 159568; lot# 218830.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00072.3002806535-2024-00073.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00072-1.3002806535-2024-00073-1.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|