INION FreedomPin Instrucciones De Uso

12000640 (2/2019-04-01)
ENGLISH
INION FreedomPin™ and INION FreedomPin™ Kit
INSTRUCTIONS FOR USE
DESCRIPTION
The INION FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of
appropriate immobilization.
The INION FreedomPin™ products are made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have
a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The
coloured pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green
No. 6, which is used in several biodegradable sutures and implants. Based on in vitro testing, the pins retain their initial strength up to 12
weeks after implantation and gradually lose their strength thereafter. Bioresorption takes place within two to four years.
The INION FreedomPin™ products are offered in different sizes and are primarily designed to be used with customized instrumentation,
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e.g. the INION K-wires, trocar tip drills, drill bits, depth gauges, pin applicators, and percutaneous and arthroscopic instruments. The INION
FreedomPin™ products are also designed to be used with ISO 9714 compatible instrumentation, i.e., K-wires and drill bits. Corresponding
INION FreedomPin™ and instrument sizes are presented in Table 1 (below).
The INION FreedomPin™ products are also provided in the sterile INION FreedomPin™ Kits containing the INION FreedomPin™
implants and the appropriate single-use instrumentation to facilitate insertion of the pins.
The INION FreedomPin™ products are sterile and non-collagenous.
INDICATIONS
The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or
bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
CONTRAINDICATIONS
The INION FreedomPin™ products should not be used in fractures and osteotomies of diaphyseal bone or in cases with insufficient quality
or quantity of bone. Other contraindications are active or potential infections, patient conditions including limited blood supply, and where
patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse). There are currently no known additional contraindications to the
use of the INION FreedomPin™ products.
INFORMATION FOR USE
Surgical considerations and reminders
• Prophylactic perioperative antibiotic treatment is recommended.
• Use proper local, regional or general anaesthesia.
• Maintain sterile field throughout the procedure.
• Proper exposure using standard surgical procedure.
• Thoroughly prepare the surgical site preserving the neurovascular structures by careful dissection.
• Good alignment/reduction of the fracture/osteotomy followed by fixation with clamp(s) and/or K-wire(s).
• Radiographs can be taken before wound closure to check the alignment/reduction after fixation.
• Meticulous hemostasis and complete primary skin closure over the implant are essential.
Instrumentation
• The INION FreedomPin™ products are primarily designed to be used with customized INION
compatible instrumentation, i.e., K-wires and drill bits. Corresponding INION FreedomPin™ diameters and instrument sizes are presented
in Table 1 (below).
Table 1. INION FreedomPin™ diameters and corresponding instrument sizes.
Implantation of the pin with reusable instruments
• When performing percutaneous pin fixation, use the INION
• When performing arthroscopic pin fixation, use the INION
• Choose appropriate INION FreedomPin™ for the application. If needed, the pins can be cut to desired length with surgical cutting pliers.
DO NOT use temperature cautery to cut or shape pins before insertion! DO NOT immerse pins in a hot water bath!
NOTE: Always rinse the drill hole before pin insertion!
• Using the appropriate (see Table 1 above) INION
rpm), drill a hole through the fracture/osteotomy plane.
• Use irrigation during drilling and irrigate the drill hole.
• Introduce the pin into the hole by hand or using the appropriate (corresponding to the pin diameter) INION
and piston. NOTE: Always ensure that 2.7 mm and 3.2 mm pins are inserted sharper tip first into the drilled hole! The pin should sink
slightly into the drilled hole. If not, widen the opening of the hole a little with the drill.
K-wire (or trocar tip
Pin diameter
drill) diameter
1.5 mm 1.5 mm
2.0 mm 2.0 mm
2.7 mm 2.7 mm
3.2 mm 3.2 mm
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percutaneous instruments.
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arthroscopic instruments.
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K-wire, trocar tip drill or drill bit attached to a slow speed drill (maximum speed of 2000
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instrumentation or general ISO 9714
Drill bit diameter
1.5 mm
2.0 mm
2.7 mm
3.2 mm
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applicator or arthroscopic tip