Patient identifier and weight not available for reporting.Patient date of birth not available for reporting, age reported as (b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.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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Patient ethnicity is unknown.Part: 323.062; lot: l659551; manufacturing location: (b)(4); release to warehouse date: november 20, 2017; 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 the product that would contribute to this complaint condition.Investigation selection investigation site: (b)(4); selected flow: 2.Device interaction / functional visual inspection: the product was returned in a packaging different to the original synthes bag.Traces of use are visible at the tip and shaft.Functional test: during the manufacturing process there is no functional test defined for this product.Therefore, this section is covered through the dimensional inspection.Dimensional inspection: all relevant features have been measured and have fulfilled the specifications -except for the sharp edges- according to the drawings.The sharp edges and free of burrs feature (position 2) was not measurable due to the heavy prior use of the device, the cutting edges are rounded and partially broken out.In addition, during the manufacturing process the lot was inspected 100% according to inspection sheets to sharp edges and free of burrs and the whole lot has passed its specifications.Drawing/specification review: the review of article and lot combination showed that there were no issues during the manufacture of the product.There were two pieces scrapped during the step related to "set-up machine", however these are not related to the complaint condition.No nc's were generated during the production of the lot in question.Summary: based on the investigation results, this complaint is rated as confirmed since the product is rounded and has partially broken out cutting edges in a manner which fits to the described complaint condition.However, from the manufacturing point of view, the relevant features were measured and have fulfilled the specifications according to the manufacturing process (see section dimensional inspection).The rounded and partially broken out cutting edges are the result of heavy prior use and is not indicated due to an error in the production process.Therefore, no manufacturing issue was identified and/or confirmed during the investigation.No corrective or preventive actions are required.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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