NA 05.001.224Recalls & reported problems

Summary

The FDA's MAUDE database contains 987 adverse event reports that list this exact device (DI 10886982130037), received between Nov 21, 2017 and Sep 30, 2026 — classified as 6 injuries, 981 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (704 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 25 most recent of 987 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the attachment device was frozen/will not move and had a worn seal. It was further determined that the device failed pretest for Check General function in running mode and check the oscillation frequency with Frequency meter. It was noted in the service order that the device did not work. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948664 ↗
• MalfunctionSep 30, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the attachment device was frozen/will not move, the coupling was loose, and there was component damage. It was further determined that the device failed pretest for General condition, Check the handpiece coupling, Check general function in running mode, and Check the oscillation frequency with Frequency meter. It was noted in the service order that prior to an unspecified surgical procedure it was observed that the device did not work anymore. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947176 ↗
• MalfunctionSep 29, 2026Mechanical Jam; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937117 ↗
• MalfunctionSep 29, 2026Mechanical Jam; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933658 ↗
• MalfunctionSep 28, 2026Complete Loss of Power; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914234 ↗
• MalfunctionSep 28, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the sagittal saw attachment device was frozen/would not move. It was noted in the service order that during pre-surgery, it was discovered that the device did not work anymore. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914101 ↗
• MalfunctionSep 17, 2026Mechanical Jam

  It was reported that during service and evaluation, it was determined that the SAGITTAL SAW ATTACHMENT device was frozen/would not move. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805298 ↗
• MalfunctionSep 17, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the sagittal saw attachment device was frozen/would not move. It was noted in the service order that the device stopped working. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804566 ↗
• MalfunctionSep 17, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the sagittal saw attachment device was frozen/would not move. It was noted in the service order that the device did not work. It was reported there were no delays to the surgical procedure and the surgery was completed as intended. It was not reported if a spare device was available for use. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802785 ↗
• MalfunctionSep 17, 2026Complete Loss of Power; Excessive Heating

  It was reported that during service and evaluation, it was determined that the sagittal saw attachment device produced heat. It was noted in the service order that the device did not work. It was reported there were no delays to the surgical procedure and the surgery was completed as intended. It was not reported if a spare device was available for use. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802567 ↗
• MalfunctionSep 16, 2026Mechanical Jam

  It was reported that during service and repair pre-testing, it was discovered that the sagittal saw attachment device was frozen/would not move. It was noted that a gradual deterioration of materials was found in the internal and external components. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787647 ↗
• MalfunctionSep 14, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the sagittal saw attachment device was frozen/would not move. It was noted in the service order that the device was not working. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755537 ↗
• MalfunctionSep 9, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699236 ↗
• MalfunctionAug 31, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519642 ↗
• MalfunctionAug 25, 2026Mechanical Jam; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432434 ↗
• MalfunctionAug 25, 2026Mechanical Jam

  It was reported that during service and evaluation, it was determined that the SAGITTAL SAW ATTACHMENT, LONG, FOR TRS device was frozen/would not move. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in (b)(6) 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429418 ↗
• MalfunctionAug 24, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410107 ↗
• MalfunctionMay 7, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115840 ↗
• MalfunctionApr 28, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE AND HAD COMPONENT DAMAGE. IT WAS NOTED THAT THE DEVICE HAD GRADUAL DETERIORATION OF MATERIALS IN THE INTERNAL AND EXTERNAL COMPONENTS. WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK GENERAL FUNCTION IN RUNNING MODE, AND CHECK THE OSCILLATION FREQUENCY WITH FREQUENCY METER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023968 ↗
• MalfunctionApr 28, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017930 ↗
• MalfunctionApr 27, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK PRIOR TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001660 ↗
• MalfunctionApr 24, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED THAT THERE WAS A GRADUAL DETERIORATION OF MATERIALS IN THE INTERNAL AND EXTERNAL COMPONENTS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982170 ↗
• MalfunctionApr 23, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW ATTACHMENT, LONG, FOR TRS DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967295 ↗
• MalfunctionApr 20, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE SAGITTAL SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER NOTED THAT A GRADUAL DETERIORATION OF MATERIALS WAS FOUND IN THE INTERNAL AND EXTERNAL COMPONENTS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925268 ↗
• MalfunctionApr 10, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW ATTACHMENT, LONG, FOR TRS DEVICE WAS FROZEN/WOULD NOT MOVE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839662 ↗