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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE; NAIL,FIXATION,BONE
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| Model Number 04.034.446S |
| Device Problem
Nonstandard Device (1420)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 07/27/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Event Description
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It was reported that on (b)(6) 2020, during a case, the consultant noticed that the tibial nail's color was blue.Nail is usually green in color.The consultant had a backup device that had a correct color.There was no surgical delay and no patient consequence.This report is for one (1) 10mm ti cann tibial nail-ex w/prox bend 330mm-sterile.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the 10mm ti cann tibial nail-ex w/prox bend 330mm-sterile (part #: 04.034.446s, lot #: 50p1493) was evaluated and investigated by jabil monument.The visual inspection shows that the complaint device was returned in its original packaging in an unopened pouches.The laser etch clearly identified the part as being from batch 50p1493.From this initial review it was determined that the order was machined correctly but anodized blue instead of light green, thus confirming the complaint condition.Document/specification review: relevant (current and manufactured to) drawing was reviewed.No design issues or discrepancies were identified.Manufacturing review: part#: 04.034.4465-us, lot#50p1493: was manufactured between 25-mar-2020 and 02-apr-2020.The order was anodized on 26-mar-2020 and the final inspection was completed on 26-mar-2020.The router correctly called out ad-lg-nail rev.N as the anodize process sheet, which requires the nail to conform to ti-b125 (light green).Ad-lg-nail rev.N also requires a 100% bulk inspection per the inspection items listed on the process sheet.The anodize operator and the second check operator signed off the operation, signifying that the nail conformed to the light green color standard on 25-mar-2020.Per the anodize work instruction for nails and the product traveler work instruction both operator 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 26-mar-2020.The anodize color was incorrectly identified as conforming to the light green color standard per ti-8125.A one year nc and capa records reviewed was conducted and no trend related to this issue was established.Process risk: risk document for the 04.034.446s-us parts was reviewed for evaluation of the risk associated with incorrect anodize color of the implant.The associated failure mode for this issue is listed below, along with the relative risk level: ¿ color of implant incorrect, surgical delay- moderate: 3, probability of occurrence: 1, risk: accept dimensional inspection: the dimensional inspection was not performed due to a definitive finding of a cosmetic defect.There was no damage that warranted a dimensional inspection.Conclusion: the overall complaint was confirmed for the 10mm ti cann tibial nail-ex w/prox bend 330mm-sterile (part #: 04.034.446s, lot #: 50p1493) as the manufacturer acknowledged that nail was anodized with the wrong color of blue instead of light green.Jabil monument has initiated for further investigation and documentation of this complaint.A depuy synthes non-conformance record has been initiated as well.A screening notice react/ pie was also raised for the remaining quantity of devices made out of bacth # 50p1493.No definitive root cause could be attributed, however the investigation determined that the issue was related to a gap in anodizing and inspection steps which are part of the overall manufacturing process.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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 02-apr-2020, expiration date: 28-feb-2029, part number: 04.034.446s, 10mm ti cann tibial nail - ex w/prox bend 330mm ¿ sterile, lot number: 50p1493 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns072607 rev b met all inspection acceptance criteria.Inspection sheet indicates that the lot was 100% inspected for anodize color of ¿light green¿ and all pieces were determined to be acceptable.Packaging label log (pll) lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn by ethicon (abq) was reviewed and determined to be conforming.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 ¿color is wrong.It needs to be green instead of blue¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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