NA 212186Recalls & reported problems
Mako Surgical Corp. · Sagittal Saw Attachment · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Mako sagittal saw attachment is a bone-cutting attachment used in robot-assisted knee surgery. Its 154 reports mostly describe cleaning residue left on the device, attachments loosening or detaching, and excess vibration when cutting. The reports include no deaths and 1 injury, and 153 are malfunctions. One recall, started in April 2019, is closed and concerns saw attachments whose bearings were not lubricated.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 153
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00848486032111), received between Sep 5, 2018 and Jan 16, 2026 — classified as 1 injury, 152 malfunctions.
The most frequently reported specific device problem is “Residue After Decontamination” (94 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Apr 25, 2019Terminated
The bearings of the saw attachments were ungreased.
Z-1824-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Residue After Decontamination94
- Mechanical Problem23
- Detachment of Device or Device Component14
- Contamination of Device Ingredient or Reagent12
- Non Reproducible Results10
- Premature Separation8
- Device Slipped6
- Noise, Audible6
Patient problems
- No Clinical Signs, Symptoms or Conditions97
- No Known Impact Or Consequence To Patient57
- No Patient Involvement6
- Muscle/Tendon Damage1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Fracture; Mechanical Problem
THE FOLLOWING INFORMATION WAS PROVIDED: STRAIGHT ATTACHMENT BROKE DURING BONE PREPARATION. SURGEON WAS CUTTING THE POSTERIOR CONDYLE WHEN THE ATTACHMENT CLEARLY BECAME LOOSE. SECOND MAKO KNEE TRAY OPENED AND STRAIGHT ATTACHMENT REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095629 ↗MalfunctionJan 5, 2026Mechanical Problem; Positioning Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968223 ↗MalfunctionDec 17, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE PROCEDURE, THIS WAS DISCOVERED DURING INSTRUMENT INSPECTION. SINCE THE PROCEDURE CONCLUDED WITHOUT INCIDENT, NO ADVERSE EVENTS OCCURRED. WHEN SECURELY ATTACHING THE SAW BLADE TO THE MAKO MICS SAGITTAL SAW STRAIGHT ATTACHMENT, LATERAL MOVEMENT WAS OBSERVED. ADDITIONALLY, THE PROTRUDING SECTION OF THE MICS CONNECTION POINT ALSO ROTATES. CONTINUED USE MAY CAUSE THE SAW BLADE TO LOOSEN DURING MICS OPERATION, SO REPLACEMENT IS REQUESTED. UPDATE ON 12/05/2025: 1. COULD YOU PLEASE ELABORATE ON WHAT YOU MEAN BY LATERAL MOVEMENT? ARE YOU REFERRING TO A WIDER OSCILLATION COMPARED TO THE REGULAR ONE? YES. DURING POSTOPERATIVE INSPECTION, IT WAS CONFIRMED THAT THE SAW BLADE WAS SECURELY FASTENED TO THE STRAIGHT ATTACHMENT, HOWEVER LATERAL MOVEMENT WAS OBSERVED BY MANUAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825985 ↗InjuryJun 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible
STRAIGHT SAW ATTACHMENT MAKES EXTREMELY LOUD NOISE WHILE EXECUTING THE CUTS WITH A NARROW BLADE. IT IS SUSPECTED THAT THE OSCILLATION MOTION IS WIDER THAN NORMAL. HALF WAY OF EXECUTING THE TIBIA CUT, IT WAS NOTICED THE PATELLAR TENDON WAS DAMAGED BY THE BLADE. IT HAD TO BE STITCHED.
Patient problems: Muscle/Tendon Damage
MAUDE report 19562149 ↗MalfunctionNov 6, 2023Residue After Decontamination; Residue After Decontamination
LEAKING OIL CASE TYPE / APPLICATION: TKA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18071736 ↗MalfunctionOct 23, 2023Difficult to Insert; Premature Separation; Difficult to Insert; Premature Separation
THE SALES REP RECEIVED THE FOLLOWING MESSAGE: "THAT ATTACHMENT NOT WORK( IT'S NOT HOLDING THE SAW BLADE). WE CANCEL THE SECOND CASE TODAY"C UPDATE: LOCKING MECHANISM FAILURE OCCURRED INTRA-OPERATIVELY. DUE TO THE FAILURE, A FOLLOWING CASE WAS CANCELLED PRIOR TO ANY PATIENT (ANESTHESIA) INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17985595 ↗MalfunctionOct 10, 2023Contamination; Residue After Decontamination; Contamination; Residue After Decontamination
SAWS STAINED STERILIZING TUBING WITH SOME OILY RESIDUE. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17906908 ↗MalfunctionOct 10, 2023Contamination; Residue After Decontamination; Contamination; Residue After Decontamination
SAWS STAINED STERILIZING TUBING WITH SOME OILY RESIDUE. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17906907 ↗MalfunctionOct 9, 2023Residue After Decontamination; Residue After Decontamination
ATTACHMENT LEAKING OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17894146 ↗MalfunctionOct 5, 2023Contamination; Residue After Decontamination; Contamination; Residue After Decontamination
SAW LEAKING FLUID/ OIL CASE TYPE / APPLICATION: TKA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17874825 ↗MalfunctionSep 18, 2023Residue After Decontamination; Residue After Decontamination
SAW LEAKING GREASE AND OIL CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17762920 ↗MalfunctionSep 18, 2023Residue After Decontamination; Residue After Decontamination
ALL SAWS LEAKING GREASE AND OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17762911 ↗MalfunctionSep 18, 2023Residue After Decontamination; Residue After Decontamination
ALL SAWS LEAKING GREASE AND OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17762906 ↗MalfunctionSep 15, 2023Residue After Decontamination; Residue After Decontamination
ALL SAWS LEAKING GREASE AND OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17760643 ↗MalfunctionSep 15, 2023Residue After Decontamination; Residue After Decontamination
ALL SAWS LEAKING GREASE AND OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17760642 ↗MalfunctionAug 25, 2023Residue After Decontamination; Residue After Decontamination
OIL LEAKING OUT OF STRAIGHT SAW ATTACHMENT IN TRAY. CONTAMINATED TRAY. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17622411 ↗MalfunctionMay 31, 2023Residue After Decontamination; Residue After Decontamination
WORN SAW ATTACHMENT- REPLACEMENT NEEDED UNABLE TO USE - RUST. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029661 ↗MalfunctionMay 26, 2023Residue After Decontamination; Residue After Decontamination
INNER MECHANISM LOOSE, OIL LEAKED. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17012242 ↗MalfunctionMay 26, 2023Residue After Decontamination; Residue After Decontamination
SPD SAYS THAT THE ATTACHMENTS ARE LEAKING LUBRICANT. THAT THEY STERILIZED THEM AND THAT WHEN OPENED IN THE ROOM THAT THERE WAS GREASE ALL OVER ALL THE INSTRUMENTS. THEY AREN'T SURE WHICH PART IS LEAKING THE LUBRICANT AND WANT TO GET NEW ONE. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17012209 ↗MalfunctionApr 28, 2023Residue After Decontamination; Noise, Audible; Residue After Decontamination; Noise, Audible
SAW AND ATTACHMENTS VERY LOUD. CHECKPOINTS AT THE EDGE OF RANGE AT 1.2 AND 1.4 FOR STRAIGHT AND SAGITTAL ATTACHMENTS. ALL PIECES SHOWING SIGNS OF WEAR WITH DARK GREASE LIKE MATERIAL AROUND MOUTH OF MICS AND ATTACHMENTS. CUTS WERE 1-2 MM DEEP BUT STILL ACCEPTABLE FOR PRESSFIT FOR SURGEON. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16830989 ↗MalfunctionApr 11, 2023Residue After Decontamination; Residue After Decontamination
OIL LEAKING FROM ATTACHMENT. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712587 ↗MalfunctionApr 7, 2023Residue After Decontamination; Residue After Decontamination
STRAIGHT SAW ATTACHMENT IS LEAKING OIL. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702347 ↗MalfunctionMar 20, 2023Residue After Decontamination; Residue After Decontamination
BOTH SAWS LEAKING FLUID. CASE TYPE / APPLICATION: TKA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16574185 ↗MalfunctionMar 20, 2023Residue After Decontamination; Residue After Decontamination
THE SAW ATTACHMENT LEAKS OIL ON VARIOUS AREAS. ADDITIONAL INFORMATION: "THE LEAKAGE WAS NOTICED PRE-OP WHEN OPENING THE INSTRUMENTS. WE HAD THEM WASH IT AGAIN BUT IT WAS STILL THE SAME PROBLEM.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16574182 ↗MalfunctionMar 7, 2023Residue After Decontamination; Residue After Decontamination
STRAIGHT SAW ATTACHMENT HAS BECOME GREASY BLACK AFTER STERILIZATION PROCESS AND WASHING PROCESS, AS IF A SEAL HAS BEEN BROKEN. OIL AND WASH WATER LEAKED FROM THE INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499227 ↗
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- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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