Additional narrative: reporter is a j&j employee.A device history record (dhr) review was conducted: visual inspection: the holding sleeve 45 for medium distractor was returned and received at us cq.Upon visual inspection, it was observed that the wing screw is broken.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection is not performed due to the post manufacturing damage.Document/specification review due to unknown manufacturing date, all the available drawings in the system were reviewed.Investigation conclusion the complaint condition was confirmed for the holding sleeve 45 for medium distractor.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - the following part/lot combination is unknown.If more information become available, the record will be re-assessed.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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