It was reported that on (b)(6) 2022, when the surgeon tried to remove the locking screw, the recess of the screw head got stripped and the screwdriver (other company¿s product) got broken.The locking screw was removed using a carbide drill eventually.The surgery was completed successfully with no surgical delay.No further information is available.This complaint involves one (1) device unk - screws: fns locking.This is report 1 of 1 for complaint (b)(4).
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Product complaint (b)(4).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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