DynaClip® Bone Fixation System- Instructions for Use | MedShape DynaClip® Bone Fixation System- Instructions for | Page 6

6.
7.
8.
9.
Pain, discomfort, or abnormal sensation due to presence of the device.
Nerve damage due to surgical trauma.
Necrosis of bone.
Intraoperative or postoperative bone fracture and/or postoperative
pain.
10. Inadequate healing.
9. STERILITY
The DynaClip implants and instruments are provided pre-sterilized in
single-use kits. Pre-sterilized implants and instrument kits should be
inspected prior to use. Implants and instruments should not be used if
package or seal is damaged.
The DynaClip Implant Kit is sterilized by exposure to gamma irradiation. Do
not re-sterilize. Do not use Implant Kits after expiration date.
The DynaClip Procedure Pack is sterilized by exposure to gamma
irradiation. Do not re-sterilize. Do not use after expiration date.
10. PATIENT COUNSELING INFORMATION
• It is the responsibility of the surgeon to provide the patient with
appropriate information prior to surgery. The surgeon should discuss
with the patient all possible risks versus potential benefits of treatment
considering the patient’s preoperative condition and expectations for
improvement in his/her condition postoperatively. The patient should
not have unrealistic expectations regarding the results that the surgery
and implant may provide. In order to make an informed decision, the
patient should clearly understand all applicable warnings, precautions,
possible intraoperative and postoperative complications, and
possible adverse effects associated with the surgical procedure and
implantation of the device.
• The patient should be provided with detailed written instructions
regarding postoperative care and the use and limitations of the device.
Postoperative care and physical therapy should be structured to
prevent excessive loading of the operative extremity until sufficient
healing has occurred. The patient should be advised that
noncompliance with postoperative instructions could lead to loss of
fixation or device failure requiring revision surgery to remove the
device. The patient should be encouraged to report to his/her surgeon
regarding any unusual changes to the operated extremity. If evidence
suggests fixation failure, breakage, or migration of the implant, an
intensified schedule of check-ups is advised and new warnings and
instructions to the patient may be necessary to further restrict acitvities.