Model Number N/A |
Device Problems
Fracture (1260); Mechanical Jam (2983)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported during a standard trans-tib acl technique, upon trying to implant the xl toggleoc the button became stuck and would not pass through the femur.The button is still in the patient.
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Manufacturer Narrative
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(b)(4).Surgical technique review and investigation determined femoral tunnel size is not called out and this contributed to the reported event.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to labeling deficiency as the surgical technique did not specify tunnel size when using a toggleloc xl implant.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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