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Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4), manufacturing date: january, 23, 2020, expiration date: march 31, 2028, part number: 04.034.355s, 9mm ti cann tibial nail - ex w/prox bend 375mm sterile, lot number: 36p4680 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet indicates that the lot was 100% inspected for color and confirmed as blue.Packaging label log (pll) lppf, lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of nail should have been blue but it was green does not indicate breakage.Therefore, review of the raw material would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the 9mm ti cann tibial nail-ex w/prox bend 375mm-sterile (part #: 04.034.355s, lot #: 36p4680) was not returned to the manufacturing facility.The provided image was investigated by (b)(4).The visual inspection of the photo of the device showed that the color was visually confirmed as light green instead of blue.Since the part is light green and not blue per ti-b020, the complaint is confirmed.Document/specification review: current and manufactured drawing was reviewed.No design issues or discrepancies were identified.(b)(4) conducted the following review.Manufacturing review: part#: 04.034.355s-us, lot#: 36p4680 was manufactured between january 8, 2020 and january 23, 2020.The order was anodized on january 9, 2020.The router correctly identified the process sheet ad-mb-nail rev.L, which requires the nail to conform to ti-b020 (blue).Ad-mb-nail also requires a 100% bulk inspection for color and cosmetics per the inspection items listed on the process sheet.Per the anodize work instruction for nails and the product traveler work instruction both sign offs signify that the nail was correctly processed and that all process requirements have been met.The batch was then inspected at final inspection on january 10, 2020.The inspection sheet was correctly identified in the routing information and correctly identified the specification of anodize per ti-b020 (blue).The anodize color was incorrectly identified as conforming to the blue color standard per ti-b020.A one-year review of capa and nonconformance was performed.Dimensional inspection: the dimensional inspection was not performed due since the device was not returned.Conclusion: the overall complaint was confirmed for the 9mm ti cann tibial nail-ex w/prox bend 375mm-sterile (part #: 04.034.355s, lot #: 36p4680) as the manufacturer acknowledged that nail was anodized with the wrong color of light green instead of blue.However, the reported condition of unable to assemble the device with the 5mm screw could not be confirm as the screw was not return and no picture of the screw was provided either.(b)(4) has initiated documentation for further investigation and documentation of this complaint.A corresponding depuy synthes non-conformance record has been initiated as well.No definitive root cause could be attributed, however based on the investigation it is likely that the issue was related to a gap in anodizing process and inspection failed to detect it.No design issues were observed during the document/specification review.Based on the investigation findings, corrective and or preventive actions will be assessed through the non-conformance records raised.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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It was reported that on an unknown date, a 9 x 375mm expert tibial nail with proximal bend was opened in a case, the nail should have been blue but it was green.The 5mm and 4mm screws were checked and it was confirmed that only the 4mm screws fit through the nail which is in the keeping of the 9mm nail.It is unknown if there was a surgical delay reported.The procedure was successfully completed.There was no patient consequence.Concomitant devices reported: screws: trauma (part number unknown, lot unknown, quantity 1).This report involves one (1) 9mm ti cann tibial nail-ex w/prox bend 375mm-sterile.This is report 1 of 2 for (b)(4).
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