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 07/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, the product location is unknown.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 a lateral femoral condyle fractured during second reaming, correct surgical technique was followed, size medium flo circular cutter was used with a size 2 spigot.Fracture occurred when power tool trigger was pulled.Power tool was a stryker 7.Fractured fragment was still viable and surgeon made a clinical decision to proceed as planned and cemented femur option was used.No additional information is available at this time.
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Event Description
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No additional information reported.
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Manufacturer Narrative
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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.This event was not confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive 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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