It was reported the length of the size laser marked on seven vitality screws does not match the size that correlates with the laser marked part number.The laser marked part number is 07.02000.118, which should be a 7.5 x 50 screw.However, the size is laser marked 7.5 x 40mm.This was found in a warehouse and did not have any patient involvement.This is report seven of seven for this event.
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H9: 3012447612-10/20/2023-001-r.Corrections in h3; note: code 02 cannot be edited/removed but this no longer applies from the initial submission.Additional information in h6: component, investigation type, findings, and conclusions, h7, and h9.Device evaluation: visual inspection of the returned device found the package states the screw's size is 7.5mm x 50mm, however the screw is laser etched 7.5mm x 40mm.The length was checked and confirmed to be 50mm, so the laser etching is incorrect.Root cause: the incorrect etching was caused by a deficiency in the manufacturing process, which appears to be related to the manual editing of a general program in which the operator inputs the size information based on a tabular drawing with information for screws of multiple sizes.Further analysis of the manufacturing deficiency is occurring through a scar as part of the capa process.Dhr review: the manufacturing records were reviewed, but the incorrect etching was not identified during part inspection.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2023-00325 through 3012447612-2023-00331.
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It was reported the length of the size laser marked on seven vitality screws does not match the size that correlates with the laser marked part number.The laser marked part number is 07.02000.118, which should be a 7.5 x 50 screw.However, the size is laser marked 7.5 x 40mm.This was found in a warehouse and did not have any patient involvement.This is report seven of seven for this event.
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