Investigation summary visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03.010.072, lot number:3314139) was returned to cq west chester for investigation.The gauge body was deformed and had scratch marks on the surface.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Measuring device used: ca122 (caliper).Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the depth gauge was deformed and had scratch marks all over it.Hence, the complaint was confirmed.A definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: part: 03.010.072, lot: 3314139, manufacturing site: (b)(4), supplier: n/a, release to warehouse date: 02 december 2009, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.
|