N/A 204992Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848486021856), received between Oct 31, 2018 and Nov 14, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2019Activation, Positioning or Separation Problem; Separation Problem; Premature Separation; Activation, Positioning or Separation Problem; Separation Problem; Premature Separation

  SLEEVE INSIDE LONG GUARD SLIPPING OUT. IT WAS NOTICED THAT THE BURR WAS COMING LOOSE DURING TIBIA BONE PREP. CASE TYPE: PKA (MICS). SURGICAL DELAY: = 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9320827 ↗
• MalfunctionAug 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  WHITE INNER SLEEVE PARTIAL CAME OUT POST-OP. MADE LOUD NOISE DURING TIBIA WALL. CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858298 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Non Reproducible Results; Detachment of Device or Device Component; Non Reproducible Results

  PLASTIC PIECE INSIDE THE BURR GUARD CAME OUT DURING BURRING. CASE TYPE: PKA. SURGICAL DELAY: 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573852 ↗
• MalfunctionApr 4, 2019Material Integrity Problem; Temperature Problem; Material Integrity Problem; Temperature Problem

  DURING A BILATERAL MPKA 3.0 CASE THE BURR GUARD BECAME DEFECTIVE. WHILE STARTING TO BURR THE POSTERIOR ASPECT OF THE FEMUR; A CIRCULAR PIECE OF THE EPOXY LINING FROM THE BURR GUARD CAME OUT INTO THE PATIENT. WHEN EXAMINING THE BURR GUARD IT LOOKED TO BE SLIGHTLY SMOKING FROM WHAT WE ANTICIPATED AS HEAT/ THE EPOXY GETTING WORKED OUT. I EXPLAINED TO THE DOCTOR WHAT THIS WAS AND WHERE IT WAS COMING FROM ALONG WITH OUR OPTIONS. I ALSO STRESSED WHILE USING THIS SAME ASSEMBLY THE IMPORTANCE OF THOROUGHLY FLUSHING OUT THE KNEE. WE FINISHED THE CASE WITH THE BURR GUARD AND ORIGINAL ASSEMBLY. FOR THE RIGHT KNEE, A NEW BURR GUARD AND ROTARY ATTACHMENT WERE OPENED AND THE SAME BURR WAS USED. THERE WERE NO ISSUES WITH THIS BURR GUARD OR ASSEMBLY ON THE RIGHT LEG. CLINICALLY THE ONLY DIFFERENCE NOTED BETWEEN SIDES AND THE ISSUE WAS WHEN BURRING THE POSTERIOR ASPECT OF THE LT LEG THERE WERE SLIGHT PATCHES OF RED FROM THE PROXIMAL BURR HITTING THE FEMUR AS WE BURRED THE MOST POSTERIOR ASPECT OF THE FEMUR. THE RIGHT SIDE WE FLEXED UP MORE AND THIS RED WAS NOT NOTICED. WAS THERE ANY HARM TO THE PATIENT OR USER: POTENTIAL FOR BURR GUARD EPOXY REMANENCE BEING LEFT BEHIND. CASE TYPE: PKA 3.0.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485712 ↗
• MalfunctionMar 15, 2019Break; Material Frayed; Break; Material Frayed

  AFTER BURRING THE MAJORITY OF THE FEMUR THE DOCTOR STOPPED AND NOTED SOMETHING ON THE BURR. AFTER INSPECTION I BELIEVED IT WAS PART OF THE LINING OF THE BURR GUARD ATTACHMENT. I EXPLAINED TO THE DOCTOR WHAT I BELIEVED THE ISSUE WAS AND OUR OPTIONS. THE CYLINDRICAL DEBRI WAS REMOVED FROM THE BURR AND THE REGISTRATION TOOL USED TO CHECK THE LENGTH OF THE BURR. UPON PASSING, AND PROCEEDING WITH BURRING; SOME MORE PIECES STARTED TO COME OUT AS WE WORKED TOWARD FINISHING THE TIBIA. CASE TYPE: PKA. PATIENT INVOLVEMENT: POTENTIAL FOR DEBRIS REMANENCES EVEN THOUGH IT WAS IRRIGATED AND SUCTIONED WELL. PATIENT HARM: NONE IMMEDIATE HOWEVER DEBRIS COULD REMAIN AND CAUSE ISSUES DOWN THE ROAD. PATIENT STATUS: THE PATIENT WAS UNDER ANESTHESIA MID CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8425566 ↗
• MalfunctionOct 31, 2018Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  SCRUB REPORTED PLASTIC PIECE STUCK ON BURR AFTER CASE. UNSURE IF PIECE CAME FROM BURR GUARD OR ROTARY ATTACHMENT CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026252 ↗