NA 511.791Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10886982238016), received between Apr 4, 2019 and Sep 17, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (39 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808598 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility; Compatibility Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD DAMAGES/BREAKS K-WIRE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT HOLD THE PINS PROPERLY. 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 24496606 ↗
• MalfunctionNov 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRE DEVICE WAS FROZEN/WOULD NOT MOVE AND COULD NOT ENGAGE ATTACHMENT-COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF ADJUSTING SLEEVE AND CHECK TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS LOCKED. 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 23579284 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WOULD NOT ATTACH TO THE COMPACT AIR DRIVE DEVICE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WILL NOT RUN. 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 AUGUST OF 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 23089967 ↗
• MalfunctionSep 9, 2025Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  IT WAS NOTED IN THE SERVICE ORDER THAT THE QUICK COUPLING DEVICE HAD A SPIT PUSHER THAT NO LONGER HELD THE SPITS. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD DAMAGES/BREAKS K-WIRE AND WILL NOT HOLD THE K-WIRE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK TOOL COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND CHECK FUNCTION IN RUNNING MODE. 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 23005192 ↗
• MalfunctionAug 18, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS JAMMED. 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 WAS BEARING WAS WORN AND THE K-WIRE DEVICE WAS DAMAGED/BROKEN. THE DEVICE ALSO FAILED PRETESTS FOR CHECK TOOL COUPLING, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND CHECK FUNCTION IN RUNNING MODE. 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 22829738 ↗
• MalfunctionAug 18, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS BROKEN. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE AND THE COUPLING ATTACHMENT COULD NOT BE ENGAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF THE ADJUSTING SLEEVE, CHECK TOOL COUPLING AND CHECK FUNCTION IN THE RUNNING MODE. 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 22829584 ↗
• MalfunctionJun 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE THREAD WAS STUCK IN THE THREADER. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE, HAD CORROSION/RUSTING/PITTING, THE COUPLING COULD NOT BE ENGAGED AND THE LOCKING MECHANISM WAS STIFF/STUCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF THE ADJUSTING SLEEVE, CHECK FUNCTION OF THE TENSION LEVER, CHECK CANNULATION OF THE ATTACHMENT, CHECK THE HANDPIECE COUPLING AND CHECK THE TOOL COUPLING. 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 22186739 ↗
• MalfunctionJun 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WIRE WAS LOCKED. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD CORROSION/RUSTING/PITTING AND WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF THE ADJUSTING SLEEVE, CHECK TOOL COUPLING AND CHECK FUNCTION IN RUNNING MODE. 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 22186532 ↗
• MalfunctionMay 17, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MEASUREMENT SELECTOR OF THE QUICK COUPLING DEVICE WAS STUCK AND THE DEVICE HAD CORROSION/RUSTING/ PITTING. 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 22041079 ↗
• MalfunctionFeb 13, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT FOLLOWING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS OVERHEATING AND MAKING A STRANGE NOISE. 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 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 21375296 ↗
• MalfunctionJan 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE COUPLING COULD NOT ENGAGE THE ATTACHMENT AND HEATED UP. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, CHECK THE TOOL 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 FIXING THE K-WIRE. 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 21199664 ↗
• MalfunctionSep 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY BRAZIL 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 WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE AND CORROSION/RUSTING/PITTING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF TENSION LEVER, CHECK THE CANNULATION OF ATTACHMENT, CHECK THE HANDPIECE COUPLING AND CHECK THE TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD WIRE JAMMED ON EQUIPMENT. 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 20170922 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING FOR K-WIRES DEVICE WAS BROKEN. 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 BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130210 ↗
• MalfunctionApr 4, 2024Device-Device Incompatibility; Compatibility Problem; Mechanical Jam; Device-Device Incompatibility; Compatibility Problem; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE MECHANICS WERE DAMAGED, WAS FROZEN/WOULD NOT MOVE, THE K-WIRE WAS BROKEN, HAD COMPONENT DAMAGE AND MADE UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF TENSION LEVER, CHECK THE TOOL COUPLING AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE THREAD WAS NOT SECURED DURING A SURGICAL PROCEDURE. THERE WAS 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 19042152 ↗
• MalfunctionDec 7, 2023Compatibility Problem; Mechanical Jam; Physical Resistance/Sticking; Compatibility Problem; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS DAMAGED/BREAKS K-WIRE AND THE THE K-WIRE COULD NOT BE SECURED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK SELF-HOLDING FORCE IN THE SMALLEST RANGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A JAMMED HEAD FOR CHANGING WIRE DIAMETER. 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 18282456 ↗
• MalfunctionNov 2, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE COUPLING COULD NOT ENGAGE THE ATTACHMENT, HAD COMPONENT DAMAGE, WOULD NOT HOLD THE K-WIRE AND WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE HANDPIECE COUPLING, CHECK THE TOOL COUPLING AND CHECK FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE "CHESTNUTS" OF THE ADAPTERS WERE LOCKED IN. 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, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057517 ↗
• MalfunctionNov 2, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE COUPLING COULD NOT ENGAGE THE ATTACHMENT, HAD COMPONENT DAMAGE, WOULD NOT HOLD THE K-WIRE AND WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE HANDPIECE COUPLING, CHECK THE TOOL COUPLING AND CHECK FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE "CHESTNUTS" OF THE ADAPTERS WERE LOCKED IN. 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, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057319 ↗
• MalfunctionOct 6, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY BRAZIL 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 AND WOULD NOT HOLD K-WIRE. IT WAS DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK THE HANDPIECE COUPLING AND CHECK THE TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD DAMAGED SPINDLE END AND BROKEN BEARING. 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 17890274 ↗
• MalfunctionSep 29, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE- CHUCK SEIZED. IT WAS FURTHER OBSERVED THAT THE K-WIRE SETTINGS COULD NOT BE CHANGED, AND THE DEVICE WOULD NOT HOLD THE K-WIRE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK FUNCTION OF TENSION LEVER, CHECK THE TOOL COUPLING AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT DEVICE HAD A FAULTY TRIGGER WIRE SYSTEM AND WAS UNABLE TO LOCK THE K-WIRE DEVICE. 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 17843643 ↗
• MalfunctionSep 19, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD A FRACTURED COUPLING, WAS FROZEN/WOULD NOT MOVE AND THE K-WIRE SETTINGS COULD NOT BE CHANGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF THE ADJUSTING SLEEVE, CHECK FUNCTION OF THE TENSIONER AND CHECK THE TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE ADAPTERS WERE LOCKED IN. 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, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774929 ↗
• MalfunctionSep 1, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM BRAZIL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE HAD DIFFICULTY TURNING AND WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670747 ↗
• MalfunctionAug 18, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS FROZEN/WOULD NOT MOVE AND CANNOT CHANGE THE K-WIRE SETTINGS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION OF THE ADJUSTING SLEEVE, CHECK THE HANDPIECE COUPLING, CHECK THE SYMMETRY OF THE HANDPIECE, CHECK THE TOOL COUPLING, CHECK SELF-HOLDING FORCE AND CHECK FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE TWINE THREADING DID NOT LOCK. 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, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572090 ↗
• MalfunctionJul 13, 2023Break; Compatibility Problem; Break; Compatibility Problem

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK QUICK COUPLING DEVICE WOULD DAMAGE/BREAK K-WIRE DEVICES. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK SELF-HOLDING FORCE IN SMALLEST RANGE. IT WAS NOTED IN THE SERVICE ORDER THAT DURING POST-SURGERY, IT WAS DISCOVERED THAT THE DEVICE HAD DAMAGED JAWS. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314670 ↗
• MalfunctionJul 6, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM BRAZIL THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WOULD NOT MOVE AND COULD NOT ENGAGE THE ATTACHMENT DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR FUNCTION OF TENSION LEVER, TOOL COUPLING AND 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 17270689 ↗