Catalog Number 04.027.038S |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.
Due to the intra-operative events, the device was not successfully implanted.
As such, implant/explant dates are not applicable.
Reporter phone number is not provided for reporting.
Device is not distributed in the united states, but is similar to device marketed in the usa.
The subject device has been received and the product evaluation is in progress.
No conclusion can be drawn.
A review of the device history records has been requested and is currently pending completion.
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 during a surgery performed on (b)(6) 2018, surgeon was unable to lock the proximal femoral nail antirotation (pfna) blade.
No consequence for the patient reported.
Surgery was completed successfully.
This report is for one (1) pfna blade perf l115 tan.
This is report 1 of 1 for complaint (b)(4).
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Event Description
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It was further reported that there was forty five (45) minutes of surgical delay.
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Manufacturer Narrative
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Additional narrative: 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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