Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Part 388.50, synthes lot 5214364, 5214365, supplier lot (b)(4): release to warehouse date: april 07, 2006.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A service and repair evaluation was completed: the customer reported the tube was loose and out of the track.The repair technician reported the tube was broken, and the spring and ratchet were worn.Worn out parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: tube, nut, ratchet, spring (set).The item was repaired and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.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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