NA 05.001.207Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10886982129734), received between Dec 12, 2017 and Mar 9, 2026 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (57 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT CLOSING. 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 24550249 ↗
• MalfunctionFeb 23, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419324 ↗
• MalfunctionAug 12, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT THE CHUCK DEVICE DID NOT WORK. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE AND FAILED PRE-TEST FOR MARKINGS AND CHECK GENERAL FUNCTION IN THE 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 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 22784830 ↗
• MalfunctionJun 6, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE CHUCK DEVICE CAME IN FOR INSPECTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE, HAD COMPONENT DAMAGE AND ILLEGIBLE ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN THE 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 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 22159788 ↗
• MalfunctionApr 22, 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 CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE - CHUCK SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884686 ↗
• MalfunctionMar 19, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE-CHUCK SEIZED, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE, HAD ILLEGIBLE LABELING ETCH AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING & LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK THE CANNULATION OF ATTACHMENT, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642704 ↗
• MalfunctionFeb 26, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE MADE NOISE AND HEAT WAS GENERATED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 21472880 ↗
• MalfunctionJan 21, 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 CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE-CHUCK SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING AND CHECK PINS LENGTH OF HANDPIECE COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 21196984 ↗
• MalfunctionJan 16, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WILL NOT MOVE ¿ CHUCK SEIZED, THE COUPLING COULD NOT ENGAGE THE ATTACHMENT, THE GEAR WAS SEIZED, AND THE ETCHING WAS WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 21172478 ↗
• MalfunctionJan 6, 2025Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE DUE TO CHUCK BEING SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE¿S ROTATION WAS DEFECTIVE. 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 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078957 ↗
• MalfunctionDec 31, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM COLOMBIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WILL NOT MOVE ¿ CHUCK SEIZED. AND THE DEVICE HAD COMPONENT DAMAGE. IT WAS NOTED THAT THE DEVICE WAS BLOCKED, MAKING IT NOT WORK AT ALL. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE, AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. 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 NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. 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 21048179 ↗
• MalfunctionJul 22, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE - CHUCK SEIZED, DID NOT FUNCTION, COUPLING COULD NOT BE ENGAGED, THE MOVING PARTS DID NOT MOVE SMOOTHLY AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM AND MINIMUM RANGE OF THE TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN THE RUNNING MODE AND CHECK FOR RUN OUT INSPECTION IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD PHYSICAL DAMAGE. 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 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801662 ↗
• MalfunctionJul 5, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE HAD THE FOLLOWING FAILURE: FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ON THE FOLLOWING: CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A COMPONENT DAMAGED. 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 BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684298 ↗
• MalfunctionJul 3, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A TRAUMA PRE-SURGERY, IT WAS DISCOVERED THAT THE DEVICE WAS NOT WORKING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665666 ↗
• MalfunctionDec 18, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE AND COULD NOT ENGAGE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE, AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS LOCKED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 18343533 ↗
• MalfunctionNov 3, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WOULD NOT MOVE, THE CHUCK WAS FROZEN, THE ETCHING WAS ILLEGIBLE AND THE COLOR BAND WAS CHIPPING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE AND MINIMUM RANGE, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE METAL WAS GRADUALLY DETERIORATING (CORROSION/RUSTING) ON THE INTERNAL COMPONENTS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. 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 18065878 ↗
• MalfunctionSep 28, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE-CHUCK SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE MAXIMUM RANGE OF TOOL COUPLING AND CHECK THE MINIMUM RANGE OF TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE PRIOR TO SURGERY. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832238 ↗
• MalfunctionJul 26, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT FUNCTION DUE TO CHUCK BEING SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE DUE TO WORN ETCH, COLOR BAND CHIPPING/FADING, AND ILLEGIBLE ETCH. IT WAS DETERMINED THAT THE DEVICE COULD NOT ENGAGE COUPLING ATTACHMENT AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING & LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK THE HANDPIECE COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK THE CANNULATION OF ATTACHMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD GRADUAL DETERIORATION OF METAL. 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 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398718 ↗
• MalfunctionJul 21, 2023Corroded; Mechanical Jam; Corroded; Mechanical Jam

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE AND FAILED PRE-TEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD CORROSION. 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 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370733 ↗
• MalfunctionJul 20, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE ETCHING WAS ILLEGIBLE AND WOULD NOT MOVE (WAS FROZEN). IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR MARKING AND LABELING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 17365127 ↗
• MalfunctionJun 20, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM SWITZERLAND, THAT DURING SERVICE AND EVALUATION. IT WAS DETERMINED, THAT THE CHUCK WITH KEY DEVICE WAS FROZEN, THE CHUCK SEIZED, THE ETCHING WAS WORN. IT WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. AND THE ETCHING WAS ILLEGIBLE. THE DEVICE ALSO FAILED PRETESTS FOR MARKING AND LABELING, DRILL CHUCK WITH KEY, MAXIMUM RANGE OF TOOL COUPLING, MINIMUM RANGE OF TOOL COUPLING AND PINS LENGTH OF HANDPIECE COUPLING. IT WAS NOTED IN THE SERVICE ORDER, THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 17163453 ↗
• MalfunctionApr 26, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE COLOR BAND WAS CHIPPING/FADING, WAS WORN, THE CHUCK SEIZED ¿ WAS FROZEN/WILL NOT MOVE, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 16817516 ↗
• MalfunctionApr 26, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE COLOR BAND WAS CHIPPING/FADING, THE ETCHING WAS WORN, THE DEVICE HAD CORROSION/RUSTING/PITTING, WAS WORN, THE CHUCK SEIZED ¿ WAS FROZEN/WILL NOT MOVE, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 16817383 ↗
• MalfunctionMar 21, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE - CHUCK SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE AND COULD NOT ENGAGE THE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK DRILL CHUCK WITH KEY, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. 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. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 16582730 ↗
• MalfunctionMar 6, 2023Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT CHUCK WITH KEY DEVICE WAS FROZEN/WOULD NOT MOVE DUE TO CHUCK BEING SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECKING DRILL CHUCK WITH KEY, CHECKING MAXIMUM RANGE OF TOOL COUPLING, CHECKING MINIMUM RANGE OF TOOL COUPLING, AND CHECKING GENERAL FUNCTION IN RUNNING MODE. 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 2023. 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 16489219 ↗