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Catalog Number 473.806S |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problems
Failure of Implant (1924); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Patient gender not reported.Date of event: unknown.(b)(4).Unknown implant/explant date; no information as to if this was a revision surgery or intraoperative event reporter telephone number unknown.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Manufacturing review showed: manufacturing location: (b)(4).Manufacturing date: 20.Aug.2015 expiry date: 01.Aug.2025 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.
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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 a proximal femoral nail antirotation (pfna) ii nail was broken at removal.The original implant date is unknown.It is also unknown if the nail was broken prior to a revision surgery or broke during a planned removal.No surgical delay or patient harm was reported.Patient status is unknown.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Patient exact weight reported as (b)(6).A manufacturing evaluation was completed: the product was returned in a packaging different from the original packaging.The laser marking was readable.Traces of use were visible and the nail is broken at citrus drill hole.A device history record review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The raw material certificates were checked and it was found that all used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed and not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and it is not confirmed from the point of view of the manufacturing site.A product investigation was completed: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence.A blade, a bolt and an end cap were also received and it determined those parts are not responsible for the breakage of the nail.No product fault could be detected.(b)(6).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 clarified that the nail was broken post-operatively.The patient was working and felt severe pain.The patient went to the doctor and an x-ray reviewed a broken nail.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional narrative: therapy date unknown.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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Concomitant devices reported: pfna-ii blade (part # 04.027.057s, lot # 9677747, qty 1).Locking bolt 4.9mm self tapping (part # 459.380, lot # 5935983, qty 1).Pfna-ii end caps (part # 473.170s, lot # 9708067, qty 1).
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Search Alerts/Recalls
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