Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Report source: event occurred in (b)(6).
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Event Description
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It was reported that during an initial tka, the surgeon was drilling through the cutting guide and the drill fractured inside of the patient's bone.The surgeon did notice this until the fragment was seen on x-ray postoperatively, and decided not to remain it.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.The product was evaluated through physical evaluation and the event was confirmed.The returned device was identified to be fractured and exhibited signs of repeated use.The device history records were reviewed and no discrepancies were identified.Based on the information available, the root cause is determined to be normal wear and tear from use during the instrument's field life.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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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.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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