WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY
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Model Number 03.037.112 |
Device Problem
Disassembly (1168)
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Patient Problem
No Code Available (3191)
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Event Date 05/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient id/initials, age/date of birth and weight are unknown.
Device is an instrument and is not implanted/explanted.
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
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 reported that on (b)(6) 2018, a patient underwent a trochanteric fixation nail advanced (tfna) procedure.
During the surgery, the surgeon tried to take off the percutaneous radiolucent insertion handle after having placed and locked down the tfna femoral nail, titanium alloy and lag screw.
However, the connecting screw for insertion handle would not release from the nail.
The patient¿s leg was abducted and the connecting screw could not be removed.
The surgeon then removed the instrumentation and implants.
A new second nail of the same part and different sized lag screw were inserted, and another new second connecting screw and insertion handle were used.
The same issue occurred.
The connecting screw became stuck to the nail while taking off the second insertion handle.
The surgeon was able to disengage the connecting screw from the nail.
The second nail and lag screw remained implanted in the patient.
It was noted that the nail was not fitting on properly, and that the tips of both insertion handles had become bent or torqued.
It was also noted that the screw inserter bent at the handle and the helical blade/screw coupling screw bent at the tip of the threads.
There was an unknown surgical delay reported.
Additional medical intervention was required.
The patient outcome was also unknown.
The procedure was successfully completed.
Concomitant device reported: trochanteric fixation nail advanced (tfna) screw 100mm - sterile (part 04.
038.
100s, lot h406590, quantity 1); trochanteric fixation nail advanced (tfna) screw 110mm - sterile (part 04.
038.
110s, lot 7859799, quantity 1).
This is report 5 of 8 for (b)(4).
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