acumed Polarus Instrucciones De Uso página 44

EN Instructions for use
- Stress, include stress from inappropriate bending of the implant during surgery
- Stress concentrations
- Stress of weight bearing, load bearing, or excessive activity
• Failure is more likely if the implant experiences increased loads due to delayed union, nonunion, or
incomplete healing. Failure is more likely if the patient does not follow post-operative care instructions.
• Nerve or soft tissue damage may result from surgical trauma or the presence of an implant.
• Instrument breakage or damage, as well as tissue damage, may occur when an instrument is subjected
to excessive loads, excessive speeds, dense bone, improper use or unintended use.
• Implants may cause distortion and/or block the view of anatomic structures on radiographic images.
Caution:
• The implants and instruments are intended only for professional use by a licensed physician.
• Do not use or re-sterilize an implant provided in sterile packaging if the package has been damaged.
The sterility may be compromised and the cleanliness of the implant may be uncertain. Report
damaged packaging to your distributor or Acumed.
• Do not use the sterile product past the use-by date. Refer to the device label.
• Do not reuse single use surgical instruments. The instrument may suddenly fail as a result of previous
stresses.
• Do not resharpen drill bits or reamers as these devices have critical dimensions and geometries that
cannot be restored once the instrument has been consumed.
• Do not use chemical disinfection methods as chemical residues may affect steam sterilization.
• Do not block holes in the case or trays, for example with labels, as this may adversely affect steam
penetration and sterilization.
• Screws, tacks, Kirschner wires, guidewires, cutting instruments, and similar devices may be sharp.
Observe hospital procedures, practice guidelines, and/or government regulations for the proper
handling and disposal of sharps.
ADVERSE EFFECTS
Possible adverse effects include:
• Pain, discomfort, or abnormal sensations, nerve or soft tissue damage, necrosis of bone or tissue, bone
resorption, or inadequate healing from the presence of an implant or due to surgical trauma.
• Implant fracture due to excessive activity, prolonged loading upon the device, incomplete healing, or
excessive force exerted on the implant during insertion. Implant migration and/or loosening may occur.
• Metal sensitivity, histological, allergic or adverse foreign body reaction resulting from implantation of a
foreign material. Consult our document "Metal Sensitivity Statement" at www.acumed.net/ifu.
SURGICAL TECHNIQUE
Acumed offers one or more Surgical Techniques to promote the safe and effective use of this system.
Consult our Surgical Techniques at www.acumed.net.
Important: Surgical techniques may contain important safety information.
English (non-U.S.) – EN / PAGE 44