Initial reporter is a synthes employee.Part 319.006, lot 5316183: release to warehouse date: september 06, 2006.Manufactured by synthes (b)(4).No non-conformance reports (ncr's) 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.A product investigation was completed: visual inspection of the complaint device showed the protection sleeve component was missing and the probe shaft was bent.Dimensional inspection showed the relevant dimensions were conforming.The current and manufactured to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the protection sleeve component was missing and the probe shaft was bent.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.
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It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that the depth gauge was a missing a piece.There was no known patient or hospital involvement.Visual inspection of the complaint device showed the protection sleeve component was missing and the probe shaft was bent.This report is for a depth gauge.This is report 1 of 1 for (b)(4).
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