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Catalog Number 473.801S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/10/2022 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the pfna for the fracture of the subtrochanteric femur.During insertion of the nail, the posterior aspect of the greater trochanter was fractured.The surgeon decided to cancel the surgery and insert a plate to fix the fracture at a later date.According to the surgeon, the patient had a medical history of femoral diaphyseal fracture in the past.The patient had undergone the osteosynthesis with a long nail.Since the femur itself had been deformed at that time, it seemed that the load applied during insertion of the nail caused the fracture in this surgery.No further information is available.This report is for one (1) pfna-ii ø10 125° l240 tan.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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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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.G4: device is not distributed in the united states, but is similar to device marketed in the usa.
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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.H6: part # 473.801s, lot # 77p3612, manufacturing site: jabil bettlach, release to warehouse date: 25.November.2020, expiry date: 01.November.2030, a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the pfna-ii ø10 125° l240 tan.Minor surface scratches are visible along the distal tip most consistent with insertion of the nail.Bone fracture cannot be confirmed as x-ray evidence was not provided.A dimensional inspection was performed for the pfna-ii ø10 125° l240 tan and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the pfna-ii ø10 125° l240 tan was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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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Search Alerts/Recalls
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