NA 05.002.001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982130464), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING A HIGH TIBIAL OSTEOTOMY SURGICAL PROCEDURE FOR A KNEE OSTEOARTHRITIS, IT WAS DISCOVERED THAT THE SURGEON USED A PLATING SYSTEM, SAW BLADE DEVICE AND AN UNKNOWN RETRACTOR DEVICE IN AN OPEN-WEDGE OSTEOTOMY FOR MEDIAL SIDE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT IMMEDIATELY AFTER THE SURGERY, THE PATIENT'S LIMBS WERE EXAMINED, AND THE PATIENT COULD NOT EXHIBIT PLANTAR FLEXION. IT WAS REPORTED THAT THE SURGEON THOUGHT IT WAS CAUSED BY THE EFFECTS OF ANESTHESIA. ACCORDING TO THE REPORTER, THE PULSE OF THE PATIENT'S FOOT WAS CONFIRMED, ALTHOUGH IT WAS ELUSIVE. HOWEVER, ON THE NIGHT OF THE SAME DAY, THE BLOOD COLOR OF THE PATIENT¿S FOOT BECAME WORSE/PALE AND THE AFFECTED AREA BECAME SWOLLEN. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EMERGENCY SURGERY IN WHICH THE SURGEON CONFIRMED AN ARTERIAL INJURY BELOW THE KNEE AND SUTURED THE BLOOD VESSEL. ACCORDING TO THE REPORTER, THE SURGEON INDICATED THAT IT WAS POSSIBLE THE RETRACTOR DEVICE, WHICH PROTECTED THE BACK POSITION MAY HAVE CHANGED OR DISLOCATED DURING THE SURGERY FOR SOME REASON AND DAMAGED THE AR

  Patient problems: Skin Discoloration; Swelling

  MAUDE report 8713214 ↗