NA 532.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 10886982240613), received between Dec 4, 2017 and Sep 18, 2026 — classified as 4 injuries, 352 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (175 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 356 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Fragmentation; Vibration; Noise, Audible

  It was reported that the QUICK COUPLING FOR K-WIRES device made a lot of noise, was vibrating and had metal dust coming out. It was not reported if the device was used in 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 50818028 ↗
• MalfunctionAug 24, 2026Mechanical Jam; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418842 ↗
• MalfunctionAug 5, 2026Compatibility Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141186 ↗
• MalfunctionJul 27, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034902 ↗
• MalfunctionMay 22, 2026Detachment of Device or Device Component; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD VIBRATION, DEFORMED/BENT - HANDLE/LEVER, FELL APART ¿ UNATTACHED, DAMAGED MECHANICS, AND DOES NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR VERSION WITH LOCKING PIN, CHECK SYMMETRY WITH HANDPIECE, AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER 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 25256392 ↗
• MalfunctionApr 15, 2026Leak/Splash; Device Slipped

  IT WAS REPORTED THAT THE QUICK COUPLING FOR K WIRE DEVICE WAS LEAKING WHAT SEEMS TO BE GREASE FROM AROUND SEAMS. THE TECHNICIAN NOTICED THAT THE SMALL RING ON THE BACK WAS NO LONGER FLUSH WITH BACK WHERE IT SITS. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT. 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 24884071 ↗
• MalfunctionMar 18, 2026Break; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE ON A CANINE PATIENT, THE QUICK COUPLING DEVICE FAILED TO GRIP THE K WIRE AND BECAME OVERHEATED. IT WAS REPORTED THAT THERE WERE NO DELAYS AND A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 24631219 ↗
• MalfunctionFeb 27, 2026Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING ATTACHMENT DEVICE HAD HEAT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK PROPERLY. 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 24475356 ↗
• MalfunctionFeb 25, 2026Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE HAD A STRANGE NOISE AND WAS OVERHEATING. 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. 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 24442109 ↗
• MalfunctionFeb 4, 2026Leak/Splash; Noise, Audible

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS LOSING A SUBSTANCE RESEMBLING GEAR OIL AND WAS PRODUCING A GRINDING SOUND WHILE SPINNING. IT WAS FURTHER REPORTED THAT THE PIN/WIRE DRIVER WAS BROKEN. 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. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS FOR VETERINARY USE ONLY. 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 24258859 ↗
• MalfunctionJan 15, 2026Device Reprocessing Problem; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS MAKING A GRITTY NOISE DURING USE, BECAME HOT TO THE TOUCH, AND BLACK DEBRIS STARTED COMING OUT FROM AROUND THE PIN GRIP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 24080111 ↗
• MalfunctionDec 5, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS GENERATING HEAT, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, WOULD NOT HOLD THE K-WIRE, THE ETCHING WAS ILLEGIBLE, AND THE DEVICE HAD CORROSION/RUSTING/PITTING, AND COMPONENT DAMAGE. IT WAS NOTED THAT THE INTERNAL COMPONENTS WERE DAMAGED, RUST WAS FOUND, WORN BEARINGS, WORN CLAMPS, WORN SEALS, AND LABELS WERE PARTIALLY ERASED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK CANNULATION OF ATTACHMENT, CHECK QUICK COUPLING FOR K-WIRE, CHECK SELF-HOLDING FORCE IN SMALLEST RANGE, CHECK SELF-HOLDING FORCE IN LARGEST 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. 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 23729165 ↗
• MalfunctionDec 5, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE WAS GENERATING HEAT, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, WOULD NOT HOLD THE K-WIRE, THE ETCHING WAS WORN, AND THE DEVICE HAD CORROSION/RUSTING/PITTING. IT WAS NOTED THAT THE INTERNAL COMPONENTS WERE DAMAGED, RUST WAS FOUND, WORN BEARINGS, WORN CLAMPS, WORN SEALS, AND LABELS WERE PARTIALLY ERASED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK FUNCTION OF ADJUSTING SLEEVE, CHECK CANNULATION OF ATTACHMENT, CHECK QUICK COUPLING FOR K-WIRE, 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. 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 23728992 ↗
• MalfunctionNov 13, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS MAKING A STRANGE NOISE AND WAS OVERHEATING. 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 23544069 ↗
• MalfunctionOct 29, 2025Vibration; Noise, Audible; Premature Separation; Vibration; Noise, Audible; Premature Separation

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE PRODUCED SEVERE NOISE, EXHIBITED VIBRATION AND THE WIRE WAS SLIPPING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. 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 23414208 ↗
• MalfunctionSep 11, 2025Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS NOT GRIPPING WIRES AND WAS SOMETIMES CHEWING THROUGH THEM. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY 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 23030699 ↗
• MalfunctionSep 3, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE; IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS MAKING A STRANGE NOISE AND OVERHEATING. THE EVENT DID NOT OCCUR DURING SURGERY. 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 22954175 ↗
• MalfunctionAug 19, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT AFTER 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 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 22838862 ↗
• MalfunctionAug 15, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT AFTER 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 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 22813917 ↗
• MalfunctionJul 29, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT DURING POST-SURGERY, IT WAS DISCOVERED THAT THE QUICK COUPLING FOR K-WIRE DEVICE OVERHEATED AND MADE 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 UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644182 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  IT WAS REPORTED THAT THE QUICK COUPLING FOR K-WIRE DEVICE DID NOT HOLD THE K-WIRE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE DAMAGED/BROKE K-WIRE AND EXHIBITED VIBRATION-UNTRUE RUNNING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK QUICK COUPLING FOR K-WIRE AND CHECK 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 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 22628702 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE SEAL DROPPED. DURING FURTHER FOLLOW UP IT WAS NOTED THAT THE GASKET IN THE EXTENSION HAD FALLEN OUT. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO DELAY 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 22587440 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE GENERATED HEAT AND WOULD NOT HOLD THE K-WIRE 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. 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 22578561 ↗
• MalfunctionJul 18, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS GENERATING HEAT. 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 ANY 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545905 ↗
• MalfunctionJul 7, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT DURING POST OP IT WAS FOUND THAT THE QUICK COUPLING DEVICE WAS OVERHEATING AND HAD A STRANGE NOISE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF 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 22419180 ↗