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WRIGHT Salvation 153910-1 Manual

Midfoot reconstruction system
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SALVATION™ Midfoot Reconstruction System
153910-1
The following languages are included in this packet:
English (en)
For additional languages, visit our website www.wright.com. Then click on the Prescribing Use option.
For additional information and translations please contact the manufacturer or local distributor.
M
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117
U.S.A.
December 2018
Printed in U.S.A.

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Summary of Contents for WRIGHT Salvation 153910-1

  • Page 1 The following languages are included in this packet: English (en) For additional languages, visit our website www.wright.com. Then click on the Prescribing Use option. For additional information and translations please contact the manufacturer or local distributor. Wright Medical Technology, Inc.
  • Page 3 Attention Operating Surgeon IMPORTANT MEDICAL INFORMATION WRIGHT MEDICAL SALVATION™ FUSION SYSTEMS (153910-1) OUTLINE: DEFINITIONS GENERAL PRODUCT INFORMATION A. PATIENT SELECTION B. CONTRAINDICATIONS C. POTENTIAL COMPLICATIONS AND ADVERSE REACTIONS D. PRECAUTIONS E. MRI SAFETY INFORMATION F. HANDLING AND STERILIZATION G. STORAGE CONDITIONS II.
  • Page 4 DEFINITIONS Symbols and abbreviations may be used on the package label. The following table provides the definition of these symbols and abbreviations. Table 1. Definitions of Symbols and Abbreviations Symbol Definition Batch code Catalog number Do not re-use Caution, consult accompanying documents Consult operating instructions Use by Temperature limitation...
  • Page 5 P[]\ Authorized EC Representative in the European Community Sterilized using ethylene oxide Sterilized using radiation Sterilized using gas plasma STERILE GAS Sterilized using aseptic processing techniques For prescription use only Abbreviation Material Titanium Ti6Al4V Titanium Alloy CoCr Cobalt Chrome Alloy Stainless Steel UHMWPE Ultra High Molecular Weight Polyethylene...

  • Page 6: General Product Information

    GENERAL PRODUCT INFORMATION Through the advancement of surgical fusion hardware, the surgeon has been provided a means of correcting deformity and reducing pain for many patients. While the implants used are largely successful in attaining these goals, it must be recognized that they are manufactured from metal, and that no implant can be expected to withstand the activity levels and loads as would normal, healthy bone after fusion occurs.

  • Page 7: Patient Selection

    A. PATIENT SELECTION Use of surgical fusion hardware requires consideration of the following general indications: • Good condition of the patient • Good neurovascular status • Adequate skin coverage • Possibility of a functional musculotendinous system • Adequate bone stock to receive implant •...
  • Page 8 C. POTENTIAL COMPLICATIONS AND ADVERSE REACTIONS In any surgical procedure, the potential for complications exists. The risks and complications with these implants include: • Infection or painful, swollen or inflamed implant site • Fracture of the implant • Loosening or dislocation of the implant requiring revision surgery •...
  • Page 9 must also be considered. Willingness and/or ability to follow post-operative instructions may also impact the surgical outcome. Surgeons must balance many considerations to achieve the best result in individual patients. IF EXCESSIVE LOADING CANNOT BE PREVENTED, AN IMPLANT SHOULD NOT BE USED.
  • Page 10 This may include a review of alternative, non-implant procedures such as soft tissue reconstruction or arthrodesis. . Recommendations Regarding Device Fragments • Use medical devices in accordance with their labeled indications and Wright Medical Technology’s instructions for use, especially during insertion and removal.
  • Page 11 Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation. • If the device is damaged, retain it to assist with Wright Medical Technology’s analysis of the event. • Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs.
  • Page 12 procedure and the potential complications that may occur. The benefits derived from implant surgery may not meet the patient’s expectations or may deteriorate with time, necessitating revision surgery to replace the implant or to carry out alternative procedures. Revision surgeries with implants are common. The patient’s mental status must also be considered.
  • Page 13 Some preventative measures to consider to minimize the potential for complications: • Follow guidelines for indications and contraindications provided above • Identify prior pathology • Stabilize collapsed deformities • Bone graft pre-existing cysts • Use a properly sized implant • Avoid K-wires and sutures through the implant •...
  • Page 14 Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation. • If the device is damaged, retain it to assist with Wright Medical Technology’s analysis of the event. • Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs.

  • Page 15: Mri Safety Information

    Since MR equipment is not standardized, the severity and likelihood of occurrence of these adverse effects are unknown for these implants. Since these devices have not been tested, Wright cannot make a recommendation for the use of MRIs with these implants, neither for safety considerations nor imaging accuracy.
  • Page 16 presented in instrument trays are provided non-sterile. Implants in sterile packaging should be inspected to ensure that the packaging has not been damaged or previously opened. The implants should be opened using aseptic OR technique; they should only be opened after the correct size has been determined. An implant should never be re-sterilized after contact with body tissues or fluids.
  • Page 17 5. Rinse with cold tap water for a minimum of one minute; use a syringe to repeatedly flush any very narrow lumens. 6. Bathe in a detergent solution prepared per manufacturer directions for 5 minutes. 7. Scrub thoroughly with a soft brush and/or pipe cleaner; repeatedly flush any very narrow lumens with detergent solution using a syringe.

  • Page 18: Storage Conditions

    The recommended instructions provided above have been validated by Wright Medical. It remains the responsibility of the processor to ensure that the processing is performed using appropriate equipment and materials and achieves the desired result. All users should be qualified personnel and properly trained on applicable policies, procedures, and standards.
  • Page 19 (Charcot). CAUTION: Federal Law (U.S.) restricts this device to sale or use by or on the order of a physician. ™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates.
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