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Catalog Number 89-8509-451-41 |
Device Problem
Unintended Ejection (1234)
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Patient Problem
Eye Injury (1845)
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Event Date 07/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Universal wire driver, micrometric, 1-4mm, part number 89-8509-451-41, serial number (b)(4), was returned for complaint investigation on the 4th of august 2021.Visual and functional tests were performed.Upon receipt, it was confirmed that the locking system that holds the wire (passive hold) had an issue.As of repair, the locking system was replaced.After repair, the device passed final tests and it was returned to the customer.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.
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Event Description
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It was reported by a chief nurse, that when the locking lever was released of the universal wire driver, micrometric, 1-4mm, part number 89-8509-451-41, serial number (b)(4) , the wire was shot out and the operating assistant was wounded in the right eyeball as it penetrated the assistant's eye.The assistant underwent the surgery to have the wire removed and a treatment to have her eye cornea stitched together.The operating assistant is still undergoing medical treatment and did not recover.This event happened during surgery with no delay reported.Further information regarding the recovery of the injured operating assistant will not be provided due to personal data protection.This new information was reported 2.5 months after the initial event ("the wire shot out"): the product was already investigated and returned to the customer at this time.
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Search Alerts/Recalls
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