A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the spot 2mm kerrison ronguer, 40 (p/n: 2929-02-240, lot #: tm1203133) was returned and received at us customer quality (cq).Upon visual inspection, the device was received fell apart due to a loose set screw.The stake on the set screw failed.There were scratches but have no impact on the functionality of the device.No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device.The device was able to reassemble and the device was able to function as intended.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawing was reviewed: 2,3 and 4 mm kerrison rongeurs, pipeline ii.Complaint confirmed? yes, the device received was fell apart.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the spot 2mm kerrison ronguer, 40 (p/n: 2929-02-240, lot #: tm1203133) there is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential root cause could be due to unintended forces applied to the device.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 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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