Catalog Number 211201405 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 approximately three (3) weeks ago, the drill broke during surgery while surgeon was drilling through the second cortex.The broken piece was removed from the patient by the surgeon, so there were not any retained pieces.Surgery was completed with a second device.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A drill bit was returned for evaluation.Visual examination of the returned product identified the drill had fractured.The drill shows signs of wear indicating use of the device.The hardness check was performed and was conforming to specifications.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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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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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