NA 111758Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486017354), received between Jun 4, 2018 and Jul 3, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MAGNET UNDER LEVEL ON 2.5 PKA END EFFECTOR FELL OUT DURING PROCEDURE. UNABLE TO USE LEVER AND SWITCH TO FOOT PEDAL FOR REMAINDER OF THE CASE. CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8760051 ↗
• MalfunctionJun 20, 2019Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE BURR DID NOT ENGAGE WHEN THE SURGEON PRESSED THE TRIGGER ON THE ANSPACH. I RESET THE CUTTER AND NO POWER TO THE ANSPACH. I RESET THE ARM SOFTWARE AND NO POWER TO THE ANSPACH. I CHANGED THE ANSPACH AND RAN A BURR STATUS CHECK WITH THE TRIGGER AND THE FOOT PEDAL AND FAILED BOTH. I DID A HARD SHUT DOWN, RE-HOMED THE ROBOT, DID ANOTHER BURR STATUS CHECK. I FAIL BOTH THE TRIGGER AND FOOT PEDAL. I FINALLY SWAPPED OUT THE END EFFECTOR AND RAN ANOTHER BURR STATUS CHECK, HOMED THE ROBOT AND PASSED THE BURR STATUS CHECK. WE SUCCESSFULLY COMPLETED THE CASE. CASE TYPE: PKA. SURGICAL DELAY: 20-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8720754 ↗
• MalfunctionSep 5, 2018No Device Output; Non Reproducible Results; No Device Output; Non Reproducible Results

  ANSPACH WAS NOT WORKING WHEN EE TRIGGER WAS PRESSED. SWITCHED ANSPACH FOR A NEW ONE AND IT STILL DID NOT WORK. AFTER TROUBLESHOOTING STEPS COMPLETED, DISCOVERED THE END EFFECTOR WAS NOT WORKING. NOT ABLE TO COMPLETE THE PROCEDURE ROBOTICALLY. ANY SURGICAL DELAY? SURGICAL DELAY OF LESS THAN 15 MIN. WAS PROCEDURE COMPLETED MANUALLY? YES, WHEN ANSPACH AND EE FAILED TO WORK THE CASE WAS COMPLETED MANUALLY. CASE TYPE: PKA. UPDATE: PER THE MPS, SHE IS NOT SURE IF THE MAGNET WAS MISSING FROM THE END EFFECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7846013 ↗
• MalfunctionJun 13, 2018Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  PKA END EFFECTOR HANDPIECE DOES NOT WORK. THE MAGNET WAS MISSING FROM THE TRIGGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598370 ↗
• MalfunctionJun 4, 2018Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  AFTER THE SURGEON BURRED OUT PART OF THE POSTERIOR TIBIA AND PROCEEDED TO PULL THE END EFFECTOR OUT TO BURR ANOTHER PORTION OF THE TIBIA, WE SAW THAT THE BURR CAME OUT OF THE END EFFECTOR. AFTER TAKING APART THE WHOLE CONSTRUCT AND CHANGING OUT THE BURR, WE REALIZED THAT THE TOP MAGNETIC CLAMP OF THE END EFFECTOR DID NOT ENGAGE CORRECTLY, CAUSING THE BURR TO BECOME LOOSE. THE END EFFECTOR WAS CHANGED OUT AND NO DAMAGE WAS DONE TO THE PATIENT. PKA CASE DELAYED =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7565336 ↗