It was reported that, while checking the instruments, it was observed that the spot 2mm kerrison ronguer, 40 was not working properly.The handpiece is no longer secured so the instrument does not close properly.No patient consequences.This report is for one (1) spot 4mm kerrison ronguer, 40.This is report 1 of 1 for complaint (b)(4).
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Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the complaint device spot 4mm kerrison ronguer, 40 (product code: 292902440, lot number: 0410tm) was returned to (b)(4) for investigation.During visual inspection, the ball and socket assembly was found detached.Functional test: the device did not work as intended as the assembly facilitating the movement of the handle was found broken.Dimensional inspection: a dimensional inspection as this was identified t be a post manufacturing damage.Document/specification review: as the manufacturing date was not available, the current revisions of the drawing were released.(b)(4) rev c (current and manufactured).Conclusion: the returned device was broken due to which the device was non-functional.Hence, the complaint was confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - as per (b)(4) manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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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