ZIMMER BIOMET, INC. TOGGLELOC ELBOW IMPLANT SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 909854 |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: expressbraid single blue/white cat#110003539 , lot#587590.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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Event Description
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It was reported after deploying the implant/tensioning, the suture/button construct snapped/failed.Surgeon used a second one with no issue.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 returned product identified that the suture was still attached to the button.Inspection of the button did not find any damages.Dimensional analysis of the button on features f1 and f14 were taken, and measurements were found to be conforming to the print.Review of the device history record(s) for part 909854 identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 is available at the time of this report.
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Search Alerts/Recalls
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