Model Number 286750031 |
Device Problem
Device Slipped (1584)
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Patient Problems
Nerve Damage (1979); Injury (2348)
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Event Date 10/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2020, during an unknown procedure, the viper prime inserter shaft came loose from the screw mid-insertion.It was still tight on the tower of the screw but where the inserter shaft meets the shank of the screw came loose, causing the tip of the screw to also be loose and therefore throwing off our navigation projection.The screw was removed from canal and attempted to be placed in pedicle three times.There was a surgical delay of fifteen to thirty (15 to 30) minutes.The patient was very close to having motor or sensory nerve issues due to screw being placed in the spinal canal.Multiple additional screw placements and o-arm spins are required.The procedure was successfully completed.The screw was thrown in the sharps disposables after the case by the hospital.The viper prime inserter shaft was inspected and appeared to be fine.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) viper prime inserter shaft.This is report 1 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Updated concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).
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Search Alerts/Recalls
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