Adverse Effects - INION FreedomPin Mode D'emploi

• Push the applicator onto the pin and press the applicator shaft to contact with the pin or introduce the pin into the arthroscopic tip. The
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INION instruments must be used to ensure proper insertion of the pin into the drill hole. During insertion of the pin, hold the applicator, or
arthroscopic tip and piston, and the pin parallel to the long axis of the drill hole to prevent bending of the pin.
• Tap the applicator shaft into the cylinder or arthroscopic piston into the tip with a small mallet so that the entire pin is forced fully into the
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drill hole. INION applicator is designed to sink the pin 1-2 mm under the cortical surface when fully inserted. This prevents the head of the
pin protruding, which could cause soft tissue irritation.
• After insertion, in addition to cutting pliers, also temperature cautery can be used to cut or shape the pin if the pin is too long or prominent.
• Two or more drill holes with fixing pins can be applied if necessary (depending on the nature and size of the fracture).
• In case a pin breaks during insertion, the broken pin can be drilled through and a new pin can be placed into the same drill hole.
• If the end result of fracture reduction or fixation is not satisfactory, the pin(s) and fixation can be removed by drilling through the pin(s).
Implantation of the pin with disposable single-use instruments included in the INION FreedomPin™ Kits
• Choose appropriate INION FreedomPin™ Kit 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!
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• Using the K-wire provided in the INION FreedomPin
Kit and attached to a slow speed drill (maximum speed of 2000 rpm), drill a hole
through the fracture/osteotomy plane.
• Use irrigation during drilling and irrigate the drill hole.
• Introduce the hooked end of the depth gauge provided in the kit into the entire depth of the drill hole. If the drill hole passes entirely through
the bone, pull back on the depth gauge until the hook catches the opposite cortex. Slide the indicator down the depth gauge until it contacts
the surface of the bone. Thereafter remove the depth gauge from the drill hole and take care not to change the position of the stop.
• Use surgical cutting pliers to cut the pin to match the distance between the hooked end and the stop of the depth gauge. DO NOT use
temperature cautery to cut or shape pins before insertion!
• Introduce the pin into the cannula provided in the kit.
• Partially insert the introducer provided in the kit into the cannula so the tip of the pin protrudes from the cannula. Introduce the pin tip into
the drilled hole. The pin should sink slightly into the drill hole. If not, widen the opening of the hole a little with the K-wire.
• Alternatively, the pin can be introduced into the hole by hand and then the cannula placed over the pin, following which the introducer is
placed into the cannula.
• Press the introducer to contact with the pin. During insertion of the pin, hold the cannula and the pin parallel to the long axis of the drill hole
to prevent bending of the pin.
• Tap the introducer into the cannula with a small mallet so that the entire pin is forced fully into the drill hole. INION
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introducer is designed
to sink the pin 1-2 mm under the cortical surface when fully inserted. This prevents the head of the pin protruding which could cause soft
tissue irritation.
• After insertion, in addition to cutting pliers, also temperature cautery can be used to cut or shape the pin if the pin is too long or prominent.
• Two or more drill holes with fixing pins can be applied if necessary (depending on the nature and size of the fracture).
• In case a pin breaks during insertion, the broken pin can be drilled through and a new pin can be placed into the same drill hole.
• If the end result of fracture reduction or fixation is not satisfactory, the pin(s) and fixation can be removed by drilling through the pin(s).
Post operative reminders
• As with any surgical procedure, careful postoperative management is important for optimal healing.
• Provide the patient with detailed instructions for postoperative care.
• Use appropriate additional immobilization (e.g. a suitable cast, brace and/or crutches) during bone healing.
• Antibiotic therapy at the discretion of the clinician.
Evaluation of results
Radiographs can be taken to evaluate bone healing.
The device is MR Safe.
WARNINGS
• The INION FreedomPin™ implants provide fixation and are not intended to replace healthy bone or withstand the stress of full load
bearing.
• Incorrect selection, placement, positioning, and fixation of the implant can cause subsequent undesirable results. The surgeon should be
familiar with the devices, the method of application and the surgical procedure prior to performing the surgery.
PRECAUTIONS
• Instruments are available to aid accurate implantation of the INION FreedomPin™ products. Surgical instruments are subject to wear with
normal usage and may break. Surgical instruments are only to be used for their intended purpose. All reusable instruments are to be
regularly inspected for wear and damage. All single-use instruments should be discarded after use! Use only appropriate instruments.
• When two or more pins are used, insert the pins at divergent angles to one another rather than parallel, for best results. When using
several pins, firstly insert the corresponding K-wires (or trocar tip drills) through the fragment and both cortices to secure the fragment.
Then remove one of the K-wires or trocar tip drills, irrigate and measure the depth of the drill hole, and insert an appropriate length pin of the
same diameter as the K-wire or trocar tip drill used into the drill hole. Thereafter, replace the other K-wires or trocar tip drills one by one in
the same manner.
• DO NOT use for unintended applications! Proper function (i.e., effectivity and safety) of these implants cannot be guaranteed in case of
off-label use.
• The patient should be warned that premature bending, loosening, breakage or migration of the pin may result from early weight bearing,
stress and activity.
SPECIAL PATIENT POPULATIONS
The effect of the INION FreedomPin™ implants upon the healing of growth plate has not been tested clinically.

ADVERSE EFFECTS

Complications are similar to those with any method of internal fixation:
• Premature bending, loosening, breakage or migration of the devices may result from early stress, activity or load bearing.
• Infection can lead to failure of the procedure.