NA 05.001.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 10886982129772), received between Dec 4, 2017 and Sep 22, 2026 — classified as 319 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (253 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 25 most recent of 319 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the reaming attachment device had a broken gear and was frozen/will not move. It was further determined that the device failed pretest for Check general function in running mode. 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. 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 50855052 ↗
• MalfunctionSep 11, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733085 ↗
• MalfunctionSep 10, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the AO REAMING ATTACHMENT FOR TRS device was frozen/would not move. It was noted in the service order that the device did not work anymore. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715902 ↗
• MalfunctionSep 9, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the reaming attachment device had a broken gear and was frozen/will not move. It was further determined that the device failed pretest for Check general function in running mode. It was noted in the service order 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 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 50691915 ↗
• MalfunctionAug 6, 2026Complete Loss of Power; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155054 ↗
• MalfunctionAug 4, 2026Mechanical Jam; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132738 ↗
• MalfunctionJul 27, 2026Mechanical Jam; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the AO REAMING ATTACHMENT FOR TRS device was frozen/would not move. It was noted in the service order that the device does not work anymore prior to a surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019919 ↗
• MalfunctionMay 5, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE, COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING, THE COLOR BAND WAS CHIPPING/FADING, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK THE HANDPIECE COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, AND CHECK GENERAL FUNCTION IN RUNNING MODE. 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 25081917 ↗
• MalfunctionApr 14, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMER ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 24874390 ↗
• MalfunctionApr 3, 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 THE COLOR BAND WAS CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT PRE-PROCEDURE IT WAS OBSERVED THAT THE DEVICE DID NOT WORK ANYMORE. 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. 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 24779193 ↗
• MalfunctionMar 30, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AO REAMING ATTACHMENT FOR TRS DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DID FUNCTION. 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. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735884 ↗
• MalfunctionMar 25, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE AO REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. 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 24685951 ↗
• MalfunctionMar 16, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AO REAMING ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING ANYMORE PRIOR TO SURGERY. 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 24611870 ↗
• MalfunctionMar 12, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AO REAMING ATTACHMENT 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. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582087 ↗
• MalfunctionMar 6, 2026Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AO REAMING ATTACHMENT FOR TRS DEVICE HEATED UP. 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. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532388 ↗
• MalfunctionFeb 27, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471524 ↗
• MalfunctionFeb 3, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WILL 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247195 ↗
• MalfunctionJan 29, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208959 ↗
• MalfunctionJan 23, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING 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. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24160194 ↗
• MalfunctionJan 9, 2026Excessive Heating

  IT WAS REPORTED THAT THE REAMING ATTACHMENT DEVICE WAS FUNCTIONING BUT OVERHEATED DURING OPERATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022076 ↗
• MalfunctionJan 5, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE REAMING ATTACHMENT DEVICE HAD COSMETIC DAMAGE AND WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKINGS AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2025. 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 23963590 ↗
• MalfunctionJan 2, 2026Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AO REAMING ATTACHMENT FOR TRS DEVICE WAS HEATING UP. 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. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23947374 ↗
• MalfunctionDec 1, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD HEAT, WAS MAKING AN UNEXPECTED NOISE, AND THERE WAS FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK FOR RUNOUT INSPECTION IN RUNNING MODE. 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 2025. 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 23687117 ↗
• MalfunctionNov 26, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD BROKEN GEAR, ECCENTRIC PIN BROKEN, BROKEN DRIVESHAFT, COLOR BAND CHIPPING/FADING AND ILLEGIBLE LABELING ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKINGS, CHECK PINS LENGTH OF HANDPIECE COUPLING AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE DEVICE DID NOT WORK ANYMORE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655206 ↗
• MalfunctionNov 24, 2025Leak/Splash; Excessive Heating; Leak/Splash; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS WORKING BUT OVERHEATED AND OIL CAME OUT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634132 ↗