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Catalog Number 459.400 |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event reported as 2018, exact date is not known.Additional product codes: hty, jdw, jds, jdn.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that patient was implanted with a proximal femoral nail antirotation (pfna) nail and two (2) bolts on (b)(6) 2018.On unknown date it was revealed that the nail and two (2) bolts were broken.This report is for one (1) locking bolt.This is report 3 of 3 for (b)(4).
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Event Description
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There were fragments generated from the broken devices.Procedure was completed successfully with no delay.Patient outcome was unknown.Concomitant devices: pfna helical blade (part: 04.027.038s, lot: unknown, quantity: 1).
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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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Code 3191 used to capture required surgical intervention and device removal.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.Part 459.440, lot 5941049: manufacturing site: salzburg.Release to warehouse date: december 08, 2016.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specifications for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was completed: reportedly the bolt was found broken postoperatively.The features were re-inspected are all the specification pertinent to the claimed issue in order to verify the conformity of returned parts.The measurable features pertinent to the complaint description are conforming to specifications.The bolt is broken post production due to use.No evidence of visual nonconformance manufacturing related.The identification confirmed that the part corresponds to the article 459.400.No evidence of non-conformances manufacturing related.The product is conforming from a manufacturing perspective.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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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Reportedly the patient was implanted with a hip prosthesis (proximal femur replacement).Updated concomitant device: pfna blade (part 04.027.038s, lot l21xxxx, quantity 1).
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Search Alerts/Recalls
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