Optetrak Logic 213-75-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862157584), received between Sep 21, 2020 and Feb 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING A BILATERAL TOTAL KNEE REPLACEMENT A DISTAL TAMP FAILED ¿THROUGH METAL FATIGUE¿. THE TAMP HAD TO BE RETRIEVED FROM THE PATIENT¿S TIBIA WITH A PAIR OF VICE GRIPS BOTH TIMES AS THERE WAS ONLY ONE ON THE KIT. THE REPORTER STATED, ¿THE PART OF THE TIBIAL TAMP THAT BROKE LOOKED LIKE METAL FATIGUED WAS THE ISSUE AS THE SMALL LIP ON THE ACTUAL TAMP HAD BROKEN OFF¿. THE DEVICE BROKE ON IMPACTION OF THE TIBIA AND WAS SEPARATED WHEN THE TAMP WAS TAKEN FROM THE TIBIA SURFACE. NO PIECES/FRAGMENTS WENT INTO THE PATIENT¿S OPERATIVE SITE, IT WAS CAPTURED IN THE IMPACTION INSTRUMENT. THERE WAS NO SURGICAL DELAY/PROLONGATION, AND NO INJURY/ ADVERSE EVENT /CLINICAL CONSEQUENCE TO THE PATIENT. THE PATIENT WAS STABLE LEAVING THE OPERATING ROOM. NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11321997 ↗
• InjurySep 21, 2020Break; Break

  IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE TIBIAL TAMP HEAD. THE ¿THUMB¿ SPRING IN THE TIBIAL TAMP LOOKS LIKE IT HAD DISENGAGED AND WOULDN'T FULLY SEAT INSIDE THE TAMP ¿ AS A RESULT THE TOP OF THE TIBIAL TAP HAS BROKEN OFF WHEN IT WAS IMPACTED INTO THE PROXIMAL TIBIA. THE SURGEON WAS EXPERIENCING DIFFICULTY IN EXTRACTING THE TIBIAL TAMP FROM THE PATIENT¿S TIBIA, DUE TO THE CONNECTION WAS NOT BROKEN AND WAS WEDGED INTO THE PROXIMAL TIBIA. THE SURGEON DID NOT APPLY RETROGRADE IMPACT OR HIT THE TAMP GUIDE IN AN ATTEMPT TO EJECT THE TIBIAL TAMP FROM THE BONE BECAUSE IT IS THE NEW STYLE TAMP FOR THE LOGIC. THE SURGEON DID NOT HAVE THE MAULDIN TOOL AVAILABLE AS AN ALTERNATIVE TO HELP EJECT THE TIBIAL TAMP, HE USED A SET OF PLYERS TO PULL THE TAMP FROM THE BONE. IT WAS CONFIRMED THAT THERE WERE NO DEVICE FRAGMENTS/PIECES LEFT IN THE PATIENT, AS NONE FELL INTO TO THE SURGICAL SITE; THIS INCLUDES THE TAMP HEAD AND ALL OTHER DEVICES. THIS EVENT RESULTED IN A 2-MINUTE SURGICAL DELAY/PROLONGATION TO RETRIEVE THE TAMP. THERE WAS NO INJURY/CLINICAL CONSEQUENCE/ADVERSE EVENT TO THE PATIENT BECAUSE OF THIS EVENT. PATIENT WAS LAST KNOWN TO B

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10562434 ↗