Occupation: reporter is a synthes employee.Part # 319.004, synthes lot # a4gr150, supplier lot # n/a, release to warehouse date: 10 dec2008, manufactured by: synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the depth gauge for 1.3mm and 1.5 mm screws (p/n: 319.004, lot #: a4gr150 was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the distal tip of the needle component was bent.Additionally, it was observed that the protection sleeve was missing.No other issues were identified.Device failure/defect identified? yes.Dimensional inspection: drawing: needle.Feature: needle diameter.Measured dimension: conforming.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Depth gauge for 1.3/1.5mm screws (current)/(manufactured).Needle (1.3/1.5) (current/manufactured).Complaint confirmed? yes.Investigation conclusion the complaint condition was confirmed for the depth gauge for 1.3mm and 1.5 mm screws (p/n: 319.004, lot #: a4gr150) as the tip of the needle was bent and the protection sleeve of the depth gauge was missing.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device and the potential cause for missing protection sleeve could be due to device incorrectly assembled during the sterilization process.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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