Catalog Number 07.02000.118 |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the length of the size laser marked on a vitality screw 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 discovered in the sterile department when placing the screw into the sterilization caddy.There was no patient involvement.This is report two of eight for this event.
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Event Description
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It was reported that the length of the size laser marked on a vitality screw 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 discovered in the sterile department when placing the screw into the sterilization caddy.There was no patient involvement.This is report two of eight for this event.
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Manufacturer Narrative
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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.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 (b)(4) for this event.
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Search Alerts/Recalls
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