NA 05.001.250Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886982130174), received between Nov 4, 2019 and Sep 28, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923245 ↗
• MalfunctionMar 5, 2026Break; Excessive Heating

  IT WAS REPORTED THAT THE AO/ASIF QUICK COUPLING FOR DRILL BITS DEVICE WAS CAUSING THE ENGINE TO OVERHEAT AND A BEARING WAS NO LONGER PROPERLY SEATED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 24527738 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE AO/ASIF QUICK COUPLING FOR DRILL BITS DEVICE, AS THE CONNECT PART IN WHICH CONNECT WITH THE DRILL BIT CAME OFF DURING THE SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220964 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE DRILL COMB DID NOT BITE WELL AND THE PINS FELL OUT. 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 22412550 ↗
• MalfunctionJul 3, 2025Appropriate Device Problem Term/Code Not Available; Premature Separation; Appropriate Device Problem Term/Code Not Available; Premature Separation

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT AND COSMETIC DAMAGE. IT WAS NOTED THAT THE TOOL COUPLING WAS DAMAGED AND THERE WAS TOOL CONNECTION FAILURE (DISCONNECTED). IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK FUNCTION OF TOOL COUPLING. 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 22395276 ↗
• MalfunctionApr 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE AO/ASIF QUICK COUPLING FOR DRILL BITS DEVICE DRILL HEAD WAS SHEARED OFF. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889051 ↗
• MalfunctionFeb 26, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE HAD HEAT AND WAS MAKING ABNORMAL NOISE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470710 ↗
• MalfunctionFeb 25, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE DRILL TIP OF THE QUICK COUPLING DEVICE WAS MOUNTED AND THE DRILL WAS POINTED UPWARD, LEFT OR RIGHT, THE DRILL TIP CAME OFF. WHEN THE DRILL WAS POINTED DOWNWARDS, THE TIP DID NOT COME OFF FROM THE QUICK COUPLING DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21460516 ↗
• MalfunctionOct 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INIUM DEVICE AND QUICK COUPLING DEVICE WERE LEAKING A LIQUID. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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. THIS IS EVENT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556548 ↗
• MalfunctionJul 22, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM HUNGARY THAT THE QUICK COUPLING DEVICE WAS OVERHEATING. 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 JANUARY 2024. 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 19792956 ↗
• MalfunctionApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM SOUTH KOREA THAT THE QUICK COUPLING DEVICE SEPARATED INTO TWO PIECES. 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. 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 19072582 ↗
• MalfunctionMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM GERMANY THAT THE BITS AND TAPS OF THE QUICK COUPLING DEVICE WERE NO LONG BLOCKED AND WERE SPONTANEOUSLY REMOVED FROM THE BIT. 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. 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 18904106 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM COLOMBIA THAT THE QUICK COUPLING DEVICE DID NOT ANCHOR THE BITS AND THEY WERE RELEASED BEFORE STARTING THE DRILL. 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 2023. 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 17304162 ↗
• MalfunctionApr 24, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED BY THE NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE PRODUCED HEAT AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR 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. 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 16793638 ↗
• MalfunctionDec 21, 2022Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LOCK OF THE QUICK COUPLING DEVICE WAS DEFECTIVE, AND THE BIT DEVICE FELL OUT DURING USE. 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 HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS FOR VETERINARY USE ONLY. 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 16023822 ↗
• MalfunctionNov 23, 2022Mechanical Jam; Excessive Heating; Mechanical Jam; Excessive Heating

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS GETTING STUCK AND OVERHEATING. 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 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852324 ↗
• MalfunctionOct 14, 2022Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED QUICK COUPLING DEVICE WAS HEATING UP AND WAS NOISY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. IT WAS NOT REPORTED 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606701 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM JAPAN THAT THE QUICK COUPLING DEVICE HAD A SCREW THAT DROPPED OFF. IT WAS NO 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 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 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461184 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE QUICK COUPLING DEVICE WAS NOT HOLDING THE LOCKS. IT WAS REPORTED THAT THEY FELL OUT SIMULTANEOUSLY. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306755 ↗
• MalfunctionApr 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY USING MHN(MULTILOC HUMERAL LONG NAIL) FOR THE BONE FRACTURE OF SHAFT OF HUMERUS, IT WAS DISCOVERED THAT THE QUICK COUPLING DEVICE DISASSEMBLED DURING INSERTION OF THE DISTAL LOCKING SCREW. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NO LONGER AVAILABLE FOR USE. IT WAS REPORTED THAT THERE WAS A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994556 ↗
• MalfunctionJan 24, 2022Excessive Heating; Excessive Heating

  THIS IS REPORT 4 OF 4 OF THE SAME EVENT: IT WAS REPORTED FROM AUSTRALIA THAT THE CHUCK DEVICE, SMALL BATTERY DRIVE DEVICE, QUICK COUPLING DEVICE, AND AO/ASIF QUICK COUPLING DEVICE WERE OVERHEATING WHILE BEING USED TOGETHER WITH THE SMALL BATTERY DRIVE CASING DEVICE. 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 SPARE DEVICES WERE AVAILABLE FOR USE. 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 13336957 ↗
• MalfunctionNov 22, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE AO/ASIF QUICK COUPLING DEVICE WAS NOT COUPLING SECURELY AND WAS UNSAFE WHILE DRILLING. IT WAS FURTHER REPORTED THAT THE ATTACHMENT DISENGAGED FROM THE HANDPIECE DEVICE. 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. 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 12852756 ↗
• MalfunctionJul 29, 2021Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE QUICK COUPLING DEVICE WOULD RELEASE THE COUPLING ELEMENTS THAT WERE PUT INTO THE DEVICE. 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 2021. 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 12247596 ↗
• MalfunctionJul 6, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE QUICK COUPLING DEVICE DRILL BIT DID NOT HOLD (THE DRILL BIT AND THE ENGAGEMENT ARE GRADUALLY LOOSENED). 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 THE 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120440 ↗
• MalfunctionApr 2, 2021Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING ATTACHMENT DEVICE HAD VIBRATION, COMPONENT DAMAGE, MOVING PARTS DID NOT MOVE SMOOTHLY, WORN BEARING AND UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR UNTRUE RUNNING/NOISE AND CHECK FOR FREE MOVEMENT. 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 2021. 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 11609547 ↗