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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Abrasion (1689)
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Event Date 07/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical devices: item number: 47-2494-240-11 , item name: retrograde nail, lot number: 61558422; item number: 47-2484-030-50 , item name: screw, lot number: 63799260 or 64377253; item number: unknown, item name: unknown jig assembly lot number: 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 during an open reduction and internal fixation, the screwdriver was used within the patient to screw down several screws.Subsequently, the screwdriver fractured.This resulted in the surgeon's hand being cut.The surgeon left the surgery to cleanse the cut, but then returned to surgery once the bleeding stopped.Attempts have been made and no additional information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to off-label usage of these devices.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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