Reported (b)(6) 2019 by surgeon.Surgeon states patient that had surgery (b)(6) 2018 had been complaining of pain in surgical knee.Pain unresolved with therapy and other measures.X-rays were obtained and revealed a piece of metal resembling the tip of an arthrex arthroscope sheath in the patient's posterior compartment.A thorough examination of all of our instrumentation was performed.An arthroscopy scope sheath was in fact found to be missing the tip of the sheath.It was immediately sequestered from use.The sheath appears to never have been welded or soldered to the tip (manufacturer defect).Local product representative was notified.Diagnosis or reason for use: arthroscopic surgery.
|