If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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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Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during the case on (b)(6) 2022, the depth gauge was very stiff and could not be used effectively to measure the length of the screws for the case.The team had to open an extra set to get a depth gauge that could be used more easily.On looking at the device, the shaft of the depth gauge was worn which was preventing it from moving smoothly.There was a ten (10) minutes procedural delay as screw kept disengaging from screwdriver.This report is for one (1) 2.7/3.5mm depth gauge 0 to 60mm.This is report 1 of 1 for complaint (b)(4).
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