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.Additional narrative: this report is for an unknown screws: trauma /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from returned photos.Visual analysis of the photo revealed that the unk - screws: trauma was broken.X-ray images provided show a nail and screw construct at the right proximal femur with an oblique displaced mal-union fracture of the bone at the distal shaft.The nail does not appear to have any defect or malfunction, however, the proximal tip is protruding from the greater trochanter cortex, this condition is most likely due to the misplaced mal-union, the nail is angled in relation to the distal fragment of the femur.The most proximal screw appears to be broken between the head and the shaft, the shaft fragment is separated from the rest of the construct, the two most distal screws are broken across the mid-shaft section, all fragments are still visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the unk - screws: trauma.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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Device report from synthes reports an event in australia as follows: it was reported that an antegrade femoral nail was implanted on (b)(6) 2017.The patient was non-compliant and has had chronic malunion after presenting to the emergency department after falling from jumping a fence.The patient experienced malunion and pain.On (b)(6) 2022, the antegrade femoral nail was removed successfully.Ria 2 was used for harvesting, and vaco implanted.It was found during visual examination performed on (b)(6) 2023 that the screws were broken in two pieces.This report involves one unk - screws: trauma.This is report 3 of 4 for (b)(4).
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