BIOMEDICAL ENTERPRISES, INC. HAMMERLOCK 2 DRILL BIT; HTY, PIN, FIXATION, SMOOTH, 21 CFR 888.3040
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Model Number DK H2 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Code Available (3191)
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Event Date 01/29/2015 |
Event Type
Injury
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Event Description
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Patient is a (b)(6) year old female who underwent hammertoe corrections of her second and third toes.The surgeon initially drilled the 3rd toe with the hl2 drill bit.However, during the course of drilling the proximal phalange shattered.The surgeon did not put an implant into the 3rd toe but tied it back together with curage wire.Next, the surgeon drilled and measured the 2nd toe and then he broached the 2nd toe but could only get the broach approximately 80-90 percent inserted into the bone.The surgeon then attempted to put in a medium hl2 implant but it would not go all the way in.So then he tried using a small hl2 implant but had a difficult time reducing the joint as there was still gaping at the joint.The surgeon removed the implant and used another means to finish the surgery.
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