Warnings and Precautionary for Gigli Saw Wire
Before using Gigli Saw Wire, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.
Gigli Saw Wire are made from surgical grade 316L Stainless Steel and are designed, constructed and produced with utmost care. These quality Gigli Saw Wire assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.
Improper use of this instrument can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.
It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of Gigli Saw Wire.
Factors which could impair the success of the operation:
- Allergies to implanted materials.
- Localized bone tumours.
- Osteoporosis or osteomalacia.
- System disease and metabolic disturbances.
- Alcohol and drug abuse.
- Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
- Patients who are mentally unable to understand and comply with the doctor’s instructions.
- Poor general health.
Possible Adverse Effects
The following adverse effects are the most common resulting from implantation:
- Loosening of the implant, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
- Early and late infection.
- Further bone fracture resulting from unusual stress or weakened bone substance.
- Temporary or chronic neural damage resulting from pressure or hematomata.
- Wound hematomas and delayed wound healing.
- Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
- Heterotopic ossification.
- Pain and discomfort due to presence of the implant.
- Mechanical failure of the implant, including bending, loosening or breakage.
- Migration of implant resulting in injury.