Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the pin driver sheared off the head of the pin and it got stuck in it.Tibial guide bottom hole did not allow a pin to penetrate it.
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Manufacturer Narrative
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Concomitant medical products: nexgen head screw catalog # 00598304033 lot # 63865617.Multiple mdr reports were filled for this event: 0001822565 - 2018 - 01851.
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Manufacturer Narrative
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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 further reported when the surgeon pinned the femoral cut guide, the pin head sheared off within the driver.The surgeon then had to forcefully hammer the cutting block off of the patient's bone which resulted in the flat surface of the pin to fracture off.The fractured pieces of the pin were retrieved from the patient's wound.The surgeon then had to cut around the pin stuck in the patient's bone until he was able to grab and remove it with a vice grip.The pin driver was unusable as the head of the pin was stuck in the driver.
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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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(b)(4).Reported event is considered confirmed as visual examination showed the device's hex head fractured off and lodged in the inserter/extractor.Sem analysis relayed that it was suspected to be fractured due to overload.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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