Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 908438 washerloc tissue fixation 18mm 528380; 908468 wshrlc fix 18mm w/4 ext spikes 624150.Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.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: 0001825034 -2019 - 00222, 0001825034 -2019 - 00225.
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Event Description
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It was reported that during an acl/mcl fixation repair procedure, the tibial bone fractured, and open reduction and internal fixation was used to repair the fracture and complete the procedure.A delay of 30 mins was noted.No additional information is available at this time.
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Event Description
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No additional information is available to report at this time.
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Manufacturer Narrative
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The following report is being submitted to relay additional information received.The complaint was confirmed based on the operative record provided stating found fracture of tibia through the drill hole that extended up into tibia bone plug harvest site and out the lateral cortex.Review of the device history records identified no related deviations or anomalies.Use error is a possible cause due insufficient quality/quantity of bone but this cannot be confirmed; therefore, root cause cannot 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.
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Search Alerts/Recalls
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