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NA 05.001.253Recalls & reported problems

Synthes GmbH · LARGE CHUCK WITH KEY DRILLING SPEED · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a Synthes large chuck with key, a powered surgical drill attachment used in orthopedic surgery. The 32 reports mostly describe the attachment coming apart during surgery or sterile processing — ball bearings or pins dropping out, the chuck separating from its stop ring, jamming or freezing so it stops working, and losing power or heating up. Reports describe 1 death and 1 injury; in most cases the events caused no harm to the patient. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
33
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982130242), received between Dec 1, 2017 and Sep 15, 2026 — classified as 1 death, 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component18
  • Complete Loss of Power5
  • Excessive Heating4
  • Material Fragmentation3
  • Premature Separation3
  • Break2
  • Device-Device Incompatibility2
  • Mechanical Jam2

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient2
  • Cardiac Perforation1
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 15, 2026Break; Material Fragmentation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50778250 ↗
  • MalfunctionAug 7, 2026Detachment of Device or Device Component; Mechanical Jam

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50172999 ↗
  • MalfunctionFeb 17, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE PIN FROM THE CHUCK WITH KEY DEVICE DROPPED OUT. 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 24367449 ↗
  • MalfunctionFeb 3, 2026Detachment of Device or Device Component; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE CHUCK ATTACHMENT DEVICE DID NOT ENGAGED PROPERLY. IT WAS FURTHER REPORTED THAT THE UPPER PART OF THE GEAR-TYPE CHUCK MOVES UPWARD AND THE BALL DETACHED. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE. 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 24248792 ↗
  • MalfunctionNov 20, 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 LARGE CHUCK WITH KEY DRILLING SPEED DEVICE BALL BEARINGS HAD FALLEN OUT SO THE PIECE WOULD NOT WORK ANYMORE. "WE DO HAVE THOSE IN A SMALL POUCH". THERE WAS NOT PATIENT INVOLVEMENT. 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 23605646 ↗
  • MalfunctionNov 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LARGE CHUCK WITH KEY DRILLING SPEED DEVICE WAS NOT WORKING. DURING FURTHER FOLLOW UP WITH THE REPORTER, IT WAS DETERMINED THAT THE FRONT PART OF THE ATTACHMENT WAS STICKING OUT AND DID NOT STAY PROPERLY ATTACHED. IT SEEMED LIKE THE DEVICE WAS FALLING APART WHILE USING THIS ATTACHMENT DURING THE OPERATION. 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 23515708 ↗
  • MalfunctionJul 21, 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 LARGE CHUCK WITH KEY DEVICE DID NOT WORK AT ALL. 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 FROZEN/WOULD NOT MOVE, WAS JAMMED/SEIZED, FELL APART - UNATTACHED AND A COMPONENT WAS DAMAGED. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION AND CHECK DRILL CHUCK FUNCTION. 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 22554239 ↗
  • MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LARGE CHUCK WITH KEY DRILLING SPEED DEVICE BALL BEARINGS WERE FALLING OUT INTO THE FRACTURE BUT IT SOUNDED LIKE THEY WERE ALL RETRIEVED. 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 WAS A VETERINARY PROCEDURE. 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 21750811 ↗
  • MalfunctionDec 22, 2023Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

    IT WAS REPORTED THAT THERE WAS AN ABNORMAL SEPARATION IN THE LARGE CHUCK WITH KEY DEVICE ITSELF. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DRILL CHUCK IS SEPARATING FROM THE STOP RING. 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. 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 18383211 ↗
  • MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM AUSTRALIA THAT THE LARGE CHUCK WITH KEY DEVICE BALL BEARINGS FELL OUT OF THE ATTACHMENT. 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. 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 18158712 ↗
  • MalfunctionNov 8, 2023Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power; Premature Separation; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power; Premature Separation

    IT WAS REPORTED THAT THE CHUCK WITH KEY DEVICE WAS BROKEN, NOT WORKING, AND NUMBERS AND MARKINGS HAD DISAPPEARED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS FURTHER DETERMINED THAT THE COLOR BAND CHIPPING/FADING, CORROSION/RUSTING/PITTING, AND ILLEGIBLE ETCH. IT WAS OBSERVED THAT THE DEVICE COULD NOT ENGAGE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK DRILL CHUCK FUNCTION, CHECK DRILL CHUCK IN SMALLEST RANGE, CHECK DRILL CHUCK IN LARGEST RANGE AND CHECK CANNULATION OF ATTACHMENT. 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 18093956 ↗
  • MalfunctionSep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE COMPACT AIR DRIVE DEVICE FELL APART-UNATTACHED AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK DRILL CHUCK FUNCTION, CHECK DRILL CHUCK IN SMALLEST RANGE, CHECK DRILL CHUCK IN LARGEST RANGE, CHECK CANNULATION OF ATTACHMENT, CHECK HANDPIECE COUPLING, CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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 17832205 ↗
  • MalfunctionApr 20, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE QUICK COUPLING DEVICE HAD SEIZED MECHANICS, WOULD NOT HOLD K-WIRE. IT WAS FROZEN AND WOULD NOT MOVE. DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK PINS LENGTH OF HANDPIECE COUPLING CONE SLEEVE. CHECK SELF-HOLDING FORCE IN SMALLEST RANGE AND CHECK FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE WHILE IN USE WITH A POWER MODULE DEVICE AND A CHUCK DEVICE. 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 16776878 ↗
  • MalfunctionDec 19, 2022Material Fragmentation; Complete Loss of Power; Material Fragmentation; Complete Loss of Power

    IT WAS REPORTED FROM KOREA THAT THE CHUCK DEVICE HAD AN IRON FILING THAT CAME OUT. 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. 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 16006222 ↗
  • MalfunctionNov 30, 2022Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CHUCK DEVICE WAS SLIPPING AND WOULD NOT HOLD OR TIGHTEN AROUND THE CUTTER DEVICE WHEN THE KEY WAS INSERTED. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 15885214 ↗
  • MalfunctionNov 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM INDONESIA THAT THE LARGE CHUCK WITH KEY DEVICE WAS BROKEN AND SPLIT INTO TWO PARTS. 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 15810794 ↗
  • MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM SOUTH KOREA THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE BALL BEARING OF THE LARGE CHUCK DEVICE CAME OUT FROM THE 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 15534387 ↗
  • InjurySep 23, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

    THIS IS EVENT 1 OF 2 OF THE SAME EVENT IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WHILE IN USE WITH THE LARGE CHUCK WITH KEY DEVICE AND THE QUICK COUPLING DEVICE THE SPINDLE CHUCK WAS SPINNING WHEN IT SHOULD NOT HAVE BEEN AND THE HANDLE WAS MISALIGNED. THIS CAUSED THE SURGEON TO INJURE THE FINGER. THE DEVICE WAS USED WITH THE SMALL BATTERY DRIVE DEVICE AND TWO QUICK COUPLING DEVICES. ACCORDING TO THE REPORTER THERE WERE NO ISSUES WITH THE SMALL BATTERY DRIVE DEVICE. THERE WAS AN UNSPECIFIED DELAY IN THE SURGICAL PROCEDURE. A SPARE SMALL BATTERY DRIVE DEVICE AND QUICK COUPLING DEVICE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE ARE NO UPDATES SO FAR ON THE SURGEON'S HEALTH. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Insufficient Information

    MAUDE report 15469845 ↗
  • MalfunctionSep 3, 2022Excessive Heating; Excessive Heating

    IT WAS REPORTED FROM SLOVAKIA THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LARGE CHUCK WITH KEY DEVICE WAS OVERHEATING. 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 2022. 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 15353619 ↗
  • MalfunctionMay 25, 2022Excessive Heating; Excessive Heating

    IT WAS REPORTED FROM JAPAN THAT THE CHUCK DEVICE GENERATED HEAT. 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 2022. 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 14498239 ↗
  • MalfunctionMay 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS DROPPED IN WATER AND WHEN GRABBED TO TAKE OUT OF THE WATER, THE BALL BEARINGS CAME OUT AND IS NOT WORKING PROPERLY. IT REPORTED THAT THIS OCCURRED DURING CLEANING OF THE DEVICE. 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 14496320 ↗
  • MalfunctionApr 29, 2022Mechanical Problem; Vibration; Detachment of Device or Device Component; Difficult or Delayed Separation; Mechanical Problem; Vibration; Detachment of Device or Device Component; Difficult or Delayed Separation

    IT WAS REPORTED FROM SOUTH KOREA THAT THE FRONT PART OF THE CHUCK DEVICE WAS SHAKING, AND THE BEARING WAS PULLED OUT. 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 14250178 ↗
  • MalfunctionJan 24, 2022Excessive Heating; Excessive Heating

    THIS IS REPORT 1 OF 5 OF THE SAME EVENT: IT WAS REPORTED FROM (B)(6) 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 13336755 ↗
  • MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM (B)(6) THAT THE FOLLOWING AN UNKNOWN SURGERY, IT WAS NOTICED THAT THE CHUCK DEVICE COMPONENTS WERE DETACHED FROM IT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 12960763 ↗
  • MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM (B)(6) THAT DURING A DISTAL RADIUS SURGERY, IT WAS DISCOVERED THAT SOME METAL BALLS DROPPED FROM THE CHUCK DEVICE. IT WAS REPORTED THAT THERE WAS A TEN MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT THE METAL BALLS WERE REMOVED FROM THE OPERATED SITE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. 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. 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 12828559 ↗

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