Additional narrative: reporter is a synthes employee.Product code: 319.004 synthes lot: 4011453 supplier lot: n/a.Release to warehouse date: (b)(6) 1999.Manufactured by: synthes brandywine no nonconformance reports (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 1.5mm screws was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the needle component of the device was bent.Also, the protection sleeve was not returned with the complaint device.No other issues were observed with the returned device.Dimensional inspection: drawing: needle (1.3/1.5) 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 1.3mm and 1.5mm screws -needle (1.3/1.5) -protection sleeve no design issues or discrepancies were identified.Investigation conclusion: this complaint was confirmed since the device was returned bent and without the protection sleeve.No definitive root cause could be determined based on the provided 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 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.
|
It was reported that during a routine incoming inspection of a loaner set at a field stocking location (fsl) on an unknown date, it was observed that the depth gauge was missing a component.There is no known patient or hospital involvement.Upon manufacturer investigation, it was determined that the needle component of the device was bent.This report is for a depth gauge for 1.3mm and 1.5mm screws.This is report 1 of 1 for pc-(b)(4).
|