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Device Problems
Misassembled (1398); Malposition of Device (2616); Misassembly by Users (3133)
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Patient Problem
No Code Available (3191)
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Event Date 01/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.This report is for an insertion handle - unknown lot; unknown part; udi unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The device is an instrument.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient experienced a surgical delay.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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The reported devices were used in surgery for femoral trochanteric fracture on (b)(6) 2018.After the implants were inserted and the incision site was closed, the surgeon found that the blade was inserted incorrectly through the nail under an x-ray image.The blade was replaced with a new one, and it took 20 minutes to finish the revision surgery.The surgeon commented that he did not properly assemble an aiming arm to the other instruments by mistake.There was an additional 60 minute delay for this patient¿s surgery.This complaint involves 3 parts.This is report 3 of 3 for (b)(4).This report is for an insertion handle.This complaint involves one (1) device.
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Manufacturer Narrative
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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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Concomitant device reported: pfna ii nail (472.103s, lot number unknown, quantity 1).
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Search Alerts/Recalls
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