Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/19/2021 |
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
|
It was reported a shim was broken.This did not occur during a surgery.
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Manufacturer Narrative
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(b)(4) review of returned item exhibits signs of repeated use and item was found disassembled.The device history records were reviewed for deviations and/or anomalies with no deviations/anomalies identified.Medical records were not provided.The root cause is considered to be a previously addressed design issue.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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