DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 7

8. PATIENT COUNSELING INFORMATION
It is the responsibility of the surgeon to provide the paMent with appropriate
informaMon prior to surgery. Prior to surgery, the surgeon should discuss with the
pa@ent all possible risks versus poten@al benefits of treatment considering the
pa@ent’s preopera@ve condi@on and expecta@ons for improvement in his/her
condi@on postopera@vely. The pa@ent should not have unrealis@c expecta@ons
regarding the results that the surgery and implant may provide. In order to
make an informed decision, the pa@ent should clearly understand all applicable
warnings, precau@ons, possible intraopera@ve and postopera@ve complica@ons
and possible adverse effects associated with the surgical procedure and
implanta@on of the device. Each pa@ent should understand that the implant is
manufactured from @tanium alloys which may cause possible reac@ons and
complica@ons, including those listed herein. The pa@ent should be informed that
the life expectancy of the device is unpredictable once implanted and that
successful results cannot be guaranteed.
The paMent should be provided with detailed wriTen instrucMons regarding
postoperaMve care, and the use and limitaMons of the device. Postopera@ve care
and physical therapy should be structured to prevent loading of the opera@ve
extremity un@l stability is evident. Pa@ents who are obese or noncompliant, as
well as pa@ents who could be predisposed to delayed union or nonunion must
have auxiliary support. Pa@ents should be cau@oned against unassisted ac@vity
that requires walking or liTing.
Any pa@ent who cannot properly u@lize weight support devices may be
par@cularly at risk during postopera@ve rehabilita@on. The pa@ent should be
advised that noncompliance with postopera@ve instruc@ons could lead to
loosening, bending or breakage of the implant, requiring revision surgery to
remove the device.The pa@ent should be encouraged to report to his/her surgeon
any unusual changes to the operated extremity. If evidence suggests loosening of
the implant (par@cularly pain and/or progressive changes in the radiographs), an
intensified schedule of check-ups is advised and new warnings and instruc@ons to
the pa@ent may be necessary to further restrict ac@vi@es.
The paMent should be encouraged to receive prompt medical aTenMon for any
infec@on that may occur, either at the surgery site or elsewhere in the body.
9. PREOPERATIVE PLANNING INFORMATION
Careful preopera@ve planning must be conducted based on radiographic findings.
Never aZempt a surgical procedure with defec@ve, damaged or otherwise
compromised instruments or implants. Inspect all components preopera@vely to
ensure that the device components and instruments are appropriate for use.
It is the physician’s responsibility to determine the correct size of the DynaNail TTC
Fusion Nail and DynaNail Screws to be implanted. The physician should always have a
full inventory of sterile DynaNail TTC Fusion Nails and DynaNail Screw sizes on hand at
the @me of surgery to ensure availability of the op@mum size for the pa@ent.