Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the service technician identified missing parts; a side screw missing.Also the general condition, tightening functional check tests have been failed.There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported.This is report 1 of 1 for (b)(4).
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Manufacturing date: february 08, 2013.Manufacturing location: (b)(4).Business group: (b)(4).Device part 03.501.080, lot 8297063 is a batch number controlled product, therefore no service history record review is possible.No non-conformance reports, rework or other relevant quality notifications were referenced in the device history record.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The conclusion of the dhr review is that the final products manufactured in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria.A service evaluation was completed: the review of the service order form from the affiliate in (b)(4) indicates the device was sent in for service.Further to this the service technician identified the following: general, missing parts and technician noted: nut and spring fault.A side screw was missing.Also the following tests have been failed: general condition, tightening functional check.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Functional testing has been performed in accordance with the service manual.The service technician identified the probable root cause as undetermined - not determinable.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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