If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter: synthes representative.Device history: part: 280.050; lot: 9611873; manufacturing site: (b)(4); release to warehouse date:14 aug 2015.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition investigation summary investigation site: (b)(4).Selected flow: 3.Damage: visual (appearance not as expected).Visual inspection: the dhs/dcs® screw was received with the reported condition of visual - damaged.The visual inspection has shown that the positioning groove of the dhs/dcs® screw is expanded and damaged.Dimensional inspection: checked dimensions with caliper: distance flat surfaces at the groove, distance flat surfaces below the groove, outer shaft diameter below the groove.Document / specification review: the returned dhs/dcs® screw was manufactured in august 2015 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The relevant feature (flat surface distance) was inspected per 100% before the part left manufacturing site.Consequently, the damage occurred is determined to be post production/acceptance criteria's.Summary: the investigation of the dhs/dcs® screw has shown that the positioning groove of the screw is damaged and widened up, this damage prevents the insertion of the plate.The review of the production history revealed that this implant was manufactured in august 2015 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.The relevant dimensions at the undamaged area were checked, and no deviation was detected.The damage occurred is determined to be post-manufacturing.It was reported, that the damage occurred pre-operative.However, the type and extent of damage incurred indicate that the positioning groove has been widened up due to inadequate handling.In order to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the appropriate dhs/dcs wrench.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.
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