Model Number N/A |
Device Problems
Fracture (1260); Difficult to Insert (1316)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 110032430; lot# 64836356; comprehensive reverse large augmented baseplate.Item# 110010424; lot# 544280; comp rvs 3.5mm hex driver.Item# 113633; lot# 054040; comp primary stem 13mm mini.Item# 110040202; lot# 64092792; compr aug 2.7 drill.Item# 110031869; lot# 64415438; comp aug ream guide bushing.Item# 110040300; lot# 64098467; compr aug mini ream gd screw.Item# 180552; lot# 498840; comp lk scr 3.5hex 4.75x25 st.Item# 180553; lot# 498930; comp lk scr 3.5hex 4.75x30 st.Item# 115397; lot# 279210; comp rvs cntrl 6.5x35mm st/rst.Item# 115323; lot# 360620; comp rvsr shldr glnsp +3 41mm.Item# 115370; lot# 602260; comp rvs tray co 44mm.Item# xl-115366; lot# 875880; acrom xl 44-41 std hmrl brng.Foreign report source: (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a comprehensive augmented reverse shoulder surgery, after impacting the augmented baseplate and having placed the 6.5 mm central compression screw inside the baseplate, 4 peripheral screws were to be inserted in the baseplate.One of the four screws got stuck in the baseplate and could not be fully inserted with the 3.5mm hex screwdriver and it would not come out either.While trying to get the screw out it broke.The surgery was completed with the broken screw.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the screw has fractured within the baseplate.No observations can be made regarding the seating issue with this image.There are no other obvious foreign bodies noted other than the broken screw.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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