Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 09/25/2019 |
Event Type
malfunction
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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.
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Event Description
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It was reported that during surgery, the small screw heads snapped off during torquing.The screws were left in the patient.Attempts have been made and no further information has been provided.
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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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The reported event was unable to confirmed as no device, images, or medical records were received.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause was unable to 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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