Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 that the surgeon was hitting the impactor with a mallet to insert the hip cup into patient.Subsequently, the impactor plate broke off with one of the surgeon¿s strikes.None of the pieces fell into the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.A g7 curved acet shell inserter, part # 110003453 from lot 158310, was returned and evaluated against the complaint.Visual inspection confirmed the strike plate to have fractured from the handle.Impact marks are present on the strike plate.The shaft is scratched and dinged consistent with a multiple use instrument.No blatant signs of misuse were observed.A review of the device history records 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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Search Alerts/Recalls
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