(b)(4).Medical devices: alps distal fibula plate pn: 8162-06-004 lot unk; 3.5x50 non locking screw pn: 1312-18-050 lot: unk; 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk; 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x18 non locking screw pn: 8150-37-018 lot: unk; 3.5x14 locking screw pn: 8162-35-014 lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10736, 0001825034-2018-10737, 0001825034-2018-10738, 0001825034-2018-10739, 0001825034-2018-10743, 0001825034-2018-10757, 0001825034-2018-10758, 0001825034-2018-10759, 0001825034-2018-10760, 0001825034-2018-10761.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Concomitant medical products¿ 3.5x18 non locking screw pn: 8150-37-018 lot: m00501 f, 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk, 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk, 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk, alps distal fibula plate pn: 8162-06-004 lot: rm145e.Complaint sample was evaluated and the reported event was confirmed.9 screws and 1 plate were returned for evaluation.The plate has a few scratches on it most likely from being explanted.3 returned screws are visually conforming to print 816135006 and overall length is conforming.There is damage to the locking threads and even the start of it to sliver.The non-locking threads shows damage to the head some worse than others.Intra-operative photos were provided and confirm the presence of black material where the plate was removed.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 unable to be determined.A summary of the investigation has been sent to the complainant.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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