NA 530.791Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10886982240262), received between Jun 18, 2018 and Jun 30, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (51 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 84 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE COULD BE GRASPED BUT WOULD NOT TURN. 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 25669771 ↗
• MalfunctionApr 11, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS LEAKING LIQUID. 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 24852589 ↗
• MalfunctionMar 19, 2026Mechanical 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 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 24639079 ↗
• MalfunctionFeb 9, 2026Device Remains Activated; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. 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 24292607 ↗
• MalfunctionJan 27, 2026Complete Loss of Power; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS NOTED THAT DURING THE PRE-TEST THE ATTACHMENT WAS NOT SYMMETRICAL ON THE REAMER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK SYMMETRY WITH HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY TESTING 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. 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 24189364 ↗
• MalfunctionJan 24, 2026Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WILL NOT MOVE AND WOULD NOT HOLD THE K-WIRE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK TOOL QUICK COUPLING AND CHECK 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 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 24173608 ↗
• MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSPECTION IN THE CLEANROOM, THE Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM DEVICE FELL APART. ACCORDING TO THE REPORTER, THE TECHNICIAN WAS GENTLY ENCOURAGING WATER OUT OF THE DEVICE WHEN IT FELL APART. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23063258 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS NOT WORKING, AND PARTS WERE DISCONNECTED. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 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 22707376 ↗
• MalfunctionJul 15, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE DIAL DID NOT MOVE SMOOTHLY AND LIQUID CAME OUT. 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 FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506829 ↗
• MalfunctionJun 13, 2025Compatibility Problem; Separation Problem; Compatibility Problem; Separation Problem

  IT WAS REPORTED THAT THE K WIRE OF THE Q COUPLING DEVICE WAS BROKEN INSIDE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE COULD NOT INSERT THE K-WIRE DEVICE, COULD NOT SECURE/DRIVE K-WIRE, AND THE SEAL WAS WORN AND THE BEARING WAS DAMAGED. THE DEVICE ALSO FAILED PRETESTS FOR CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF LEVER, CHECK THE CANNULATION OF ATTACHMENT, CHECK THE SYMMETRY WITH HANDPIECE, CHECK THE TOOL QUICK COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND CHECK SELF-HOLDING FORCE IN LARGEST RANGE. 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 22203853 ↗
• MalfunctionMay 19, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE Q-COUPLING FOR KWIRES DEVICE AUTOMATICALLY OPENED WHILE RUNNING TIME SEPARATED FROM THE GEAR AND BEARING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF DELAYS TO THE 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 22046497 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power

  IT WAS REPORTED THAT SOME SCREWS FROM THE QUICK COUPLING DEVICE BECAME DISENGAGED, AND THE HANDLE ALSO BECAME DETACHED FROM ITS POSITION. 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 22021562 ↗
• MalfunctionMay 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE HAD ALL OF THE INSIDE PARTS COME OUT. 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 FOR USE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941142 ↗
• MalfunctionApr 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE END OF THE DRIVER WAS NOT MOVING ON THE QUICK COUPLING DEVICE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929158 ↗
• MalfunctionMar 3, 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 Q-COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK 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 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 21505101 ↗
• MalfunctionJan 9, 2025Material Fragmentation; Complete Loss of Power; Material Fragmentation; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE Q-COUPLING FOR KWIRES AND PINSDIAMETER DEVICE HAD CRACKED, COULD NOT CHANGE THE K-WIRE SETTINGS, BROKEN (TWO PLUS PIECES), WAS CHIPPED/SHAVED/DELAMINATED, WOULD NOT HOLD K-WIRE, THE HANDLE/LEVER WAS LOOSE AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF LEVER, CHECK THE CANNULATION OF ATTACHMENT, CHECK THE TOOL QUICK COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE, CHECK SELF-HOLDING FORCE IN LARGEST RANGE AND CHECK 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 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 21114497 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Complete Loss of Power; Detachment of Device or Device Component; Complete Loss of Power

  IT WAS REPORTED BY INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE FELL APART ¿ UNATTACHED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COMPONENT DAMAGE, WOULD NOT HOLD THE K-WIRE AND COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF LEVER, CHECK THE CANNULATION OF ATTACHMENT, CHECK THE HANDPIECE COUPLING AND CHECK THE TOOL QUICK 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 20450513 ↗
• MalfunctionJul 18, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRES DEVICE HAD THE FOLLOWING FAILURES: FROZEN/WILL NOT MOVE AND CANNOT ENGAGE ATTACHMENT - COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ON THE FOLLOWING: CHECK FUNCTION OF ADJUSTING SLEEVE AND CHECK THE TOOL QUICK 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. 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 19772946 ↗
• MalfunctionJul 9, 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 QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK 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 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702204 ↗
• MalfunctionJun 28, 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 QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE COULD NOT ENGAGE ATTACHMENT COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK THE TOOL QUICK COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE, CHECK SELF-HOLDING FORCE IN LARGEST RANGE AND CHECK 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 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 19634668 ↗
• MalfunctionJun 24, 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 QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK 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 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595024 ↗
• MalfunctionMay 22, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION IN THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370938 ↗
• MalfunctionApr 29, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD CORROSION/RUSTING/PITTING, HEAT, COSMETIC, VIBRATION AND CANNOT SECURE/DRIVE K-WIRE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK SELF-HOLDING FORCE IN THE SMALLEST RANGE AND CHECK FUNCTION IN THE 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 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 19200321 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY INDIA THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE QUICK COUPLING DEVICE PIN WAS OUT FROM THE ATTACHMENT. 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 19030758 ↗
• MalfunctionMar 8, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE Q COUPLING FOR K WIRE DEVICE WOULD NOT HOLD THE K WIRE, THE COUPLING WAS WORN, THE MECHANICS SEIZED AND WAS FROZEN (WOULD NOT MOVE). THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION AND CHECK SELF-HOLDING FORCE IN SMALLEST RANGE. 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 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 18865054 ↗