Catalog Number 00236017520 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign-(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 drill bit was found broken before the surgery.There was no patient involvement or harm to the patient as a result of this malfunction.
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Manufacturer Narrative
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(b)(4).Visual inspection of the provided pictures noted the tip of the drill fractured, confirming the complaint.Device history record (dhr) was reviewed and no discrepancies were found.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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Event Description
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No additional event information is available at the time of this report.
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Search Alerts/Recalls
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