Model Number 02.231.285 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is lawyer.Without a lot number the device history records review could not be completed.Product was not returned.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, the medical records received on february 25, 2022, the patient underwent an open reduction internal fixation (orif) distal femur fracture due to right periprosthetic distal femur fracture.On (b)(6) 2022 the patient had a revision due to nonunion right distal femur shaft fracture about total knee arthroplasty (tka).This report is for one (1) 5.0mm variable angle lockng screw/slf-tpng/strdrv/85mm.This is report 9 of 11 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the 5.0 va lockng scr slf-tpng/sd/85 had no defect found on it.There is no evidence to confirm any defect on the device.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 not confirmed for the 5.0 va lockng scr slf-tpng/sd/85.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 history lot: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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.D10: concomitant devices added.Date of concomitant therapy is (b)(6) 2022.
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Search Alerts/Recalls
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