Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, during a procedure the depth gauge snapped at the base of the measurer while measuring for locking screws due to wear and tear of a set that is used regularly.Procedure was completed successfully using another set of instrument, with a ten(10) minutes surgical delay.This report is for one (1) depth gauge f/lock-scr meas-range-110 f/.This is report 1 of 3 for complaint (b)(4).
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Reporter is a j&j sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.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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