Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 synthes reports an event in (b)(6) as follows: during a surgery, nurses identified that the tip of the depth gauge had become bent.The surgeon confirmed that the item no longer functioned correctly as intended.The surgery finished successfully as planned.After surgery, the depth gauge was discarded.There is no further information available.This report is for one (1) 2.0/2.4mm depth gauge 50mm.This is report 1 of 1 for (b)(4).
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