(b)(4).Concomitant medical products: catalog #: 00235700706, distal medial tibial plate right 6 holes, lot # unknown.Catalog #: 00235901235, 3.5 mm locking screw 12 mm length, lot # unknown.Catalog #: 00235901835, 3.5 mm locking screw 18 mm length, lot # unknown.Catalog #: 00235902835, 3.5 mm locking screw 28 mm length, lot # unknown.Catalog #: 00235903235, 3.5 mm locking screw 32 mm length, lot # unknown.Catalog #: 00235903635, 3.5 mm locking screw 36 mm length, lot # unknown.Catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown.Catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown catalog #: 00235904035, 3.5 mm locking screw 40 mm length, lot # unknown.Catalog #: 00235904235, 3.5 mm locking screw 42 mm length, lot # unknown.Catalog #: 00483501801, 3.5 mm cortical screw self-tapping 18 mm length, lot # unknown.Catalog #: 00483502601, 3.5 mm cortical screw self-tapping 26 mm length, lot # unknown.Catalog #: 00483503801, 3.5 mm cortical screw self-tapping 38 mm length, lot # unknown.Catalog #: 233240040, vpc screw 4.0x40mm, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00567, 0001822565-2021-00568, 0001822565-2021-00570, 0001822565-2021-00571, 0001822565-2021-00572, 0001822565-2021-00573, 0001822565-2021-00574, 0001822565-2021-00575, 0001822565-2021-00578, 0001822565-2021-00579, 0001822565-2021-00580, 0001822565-2021-00581, 0001825034-2021-00610.
|
(b)(4).Updated: b4, b5, b7, g3, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was found to to traced to patient condition and non-device related factors.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.
|