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NA 05.001.208Recalls & reported problems

Synthes GmbH · CHUCK/KEYLESS/DRILL SPEED FOR TRAUMA RECON SYSTEM · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes keyless drill chuck is a surgical handpiece component used with the Trauma Recon system to hold and drive drill bits. The 43 reports describe chucks that seized or froze and would not turn, would not engage attachments, or stopped working entirely — most often found during servicing, with no mention of surgery or patient involvement. There are no deaths and no injuries among the reports, and 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
45
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10886982129758), received between Apr 5, 2019 and Sep 17, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (35 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.

Reports received per month

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

Most reported problems

Device problems

  • Mechanical Jam35
  • Complete Loss of Power33
  • Excessive Heating4
  • Break2
  • Device-Device Incompatibility2
  • Overheating of Device2
  • Appropriate Device Problem Term/Code Not Available1
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions41
  • No Consequences Or Impact To Patient4

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 17, 2026Detachment of Device or Device Component; Complete Loss of Power

    It was reported that during service and evaluation, it was determined that the chuck device fell apart ¿ unattached. It was noted in the service order that the device did not work. It was reported there were no delays to the surgical procedure and the surgery was completed as intended. It was not reported if a spare device was available for use. There was 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 50802783 ↗
  • MalfunctionSep 14, 2026Mechanical Jam; Complete Loss of Power

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50756730 ↗
  • MalfunctionSep 11, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS NOTED IN THE SERVICE ORDER THAT THE CHUCK DEVICE DID NOT WORK. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS FROZEN/WOULD NOT MOVE- CHUCK SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD COSMETIC DAMAGE ¿ WORN AND THE ETCHING ON THE LABELING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 23027336 ↗
  • MalfunctionApr 2, 2025Device-Device Incompatibility; Mechanical Jam; Complete Loss of Power; Device-Device Incompatibility; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE ¿ CHUCK SEIZED, COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND THE DEVICE HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK THE CANNULATION OF ATTACHMENT, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HELD THE DRILL POORLY. IT WAS NOTED THAT WHEN APPLIED TO THE BONE, THE DRILL SLIDES IN THE HOLDER AND STOPS. 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 21752374 ↗
  • MalfunctionFeb 11, 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 KEYLESS CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE-CHUCK SEIZED, MOVING PARTS DID NOT MOVE SMOOTHLY, DID NOT FUNCTION AND COULD NOT ENGAGE ATTACHMENT-COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21355397 ↗
  • MalfunctionJan 31, 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 CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE - CHUCK SEIZED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF THE TOOL COUPLING AND CHECK THE MINIMUM RANGE OF THE TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21283242 ↗
  • MalfunctionNov 26, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT THE KEYLESS CHUCK DEVICE DID NOT ROTATE. 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 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 20784143 ↗
  • MalfunctionSep 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 CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 20293060 ↗
  • MalfunctionFeb 26, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN (WOULD NO MOVE), THE SHAFT WAS STUCK AND WAS NOT WORKING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 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 18777745 ↗
  • MalfunctionJan 29, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE MECHANICS SEIZED AND WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 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 18594644 ↗
  • MalfunctionOct 13, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE DUE TO WORN ETCH AND ILLEGIBLE ETCH. IT WAS DETERMINED THAT THE MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKINGS, CHECK THE DRILL CHUCK BY HAND, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL 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 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 17930296 ↗
  • MalfunctionAug 17, 2023Mechanical 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 KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 NOT REPORTED, 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 WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17567499 ↗
  • MalfunctionJun 7, 2023Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE COLOR BAND WAS CHIPPING, THE ETCHING AND COUPLING WERE WAS WORN, THE DEVICE HAD COSMETIC DAMAGE (WORN), AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, MARKINGS, CHECK PINS LENGTH OF HANDPIECE COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A DAMAGED HOSE. 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 17080857 ↗
  • MalfunctionMay 26, 2023Mechanical 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 KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 NOT REPORTED, 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 WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17010201 ↗
  • MalfunctionMar 30, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED BY SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK DEVICE HAD SEIZED MECHANICS, WAS FROZEN/WOULD NOT MOVE, HAD COMPONENT DAMAGE AND CORROSION/RUSTING/PITTING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT, CHECK GENERAL FUNCTION IN RUNNING MODE AND CHECK FOR RUN-OUT INSPECTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT WHILE TESTING DURING REPROCESSING, IT WAS OBSERVED THAT THE DEVICE WAS NON FUNCTIONAL ALONG WITH A SMALL BATTERY DRIVE DEVICE. THE EVENT WAS NOT RELATED TO SURGERY. 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 16642029 ↗
  • MalfunctionFeb 22, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE, THE COLOR BAND WAS CHIPPING/FADING, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKINGS, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT 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 16417352 ↗
  • MalfunctionFeb 22, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT 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 16417215 ↗
  • MalfunctionFeb 10, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK KEYLESS DEVICE COLOR BAND WAS CHIPPING/FADING, THE ETCHING WAS WORN AND ILLEGIBLE AND THE DEVICE WAS FROZEN - WOULD NOT MOVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR GENERAL CONDITION, MARKINGS, DRILL CHUCK BY HAND, MAXIMUM RANGE OF TOOL COUPLING AND MINIMUM RANGE OF TOOL COUPLING. 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 16354853 ↗
  • MalfunctionFeb 10, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEYLESS DEVICE COLOR BAND WAS CHIPPING/FADING, THE ETCHING WAS WORN AND ILLEGIBLE, HAD COSMETIC DAMAGE AND WOULD NOT MOVE - FROZEN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR MARKINGS, MECHANICAL FREE MOVEMENT AND GENERAL 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 16354054 ↗
  • MalfunctionJan 19, 2023Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED FROM SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WILL NOT MOVE, JAMMED/SEIZED. IT WAS NOTED THAT THE ATTACHMENT SEIZED, AND WAS UNABLE TO RUN, THE HOUSING SEIZED AND WAS UNABLE TO DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE SPOILED. 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 16204562 ↗
  • MalfunctionNov 11, 2022Mechanical 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 CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE- CHUCK SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD A COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING, CHECK THE MINIMUM RANGE OF TOOL COUPLING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL 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 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 15780350 ↗
  • MalfunctionNov 9, 2022Mechanical 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 CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE- CHUCK SEIZED. IT WAS FURTHER OBSERVED THAT THE DEVICE COULD NOT ENGAGE THE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE DRILL CHUCK BY HAND, CHECK THE MAXIMUM RANGE OF TOOL COUPLING AND CHECK THE MINIMUM RANGE OF TOOL COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WOULD NOT OPERATE AT ALL. 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 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 15759138 ↗
  • MalfunctionAug 15, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED BY COSTA RICA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION AND MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECKING FOR MECHANICAL FREE MOVEMENT AND CHECKING GENERAL 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 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 15223386 ↗
  • MalfunctionJul 6, 2022Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

    IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COLOR BAND CHIPPING/FADING AND ILLEGIBLE ETCH. IT WAS DETERMINED THAT THE DEVICE DID NOT FUNCTION AND ITS MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECKING FOR MECHANICAL FREE MOVEMENT, AND CHECKING GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. 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 14941075 ↗
  • MalfunctionJun 10, 2022Unintended System Motion; Complete Loss of Power; Unintended System Motion; Complete Loss of Power

    IT WAS REPORTED BY RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE KEYLESS CHUCK DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD ILLEGIBLE ETCH, COLOR BAND CHIPPING/FADING, CORROSION/RUSTING/PITTING, AND COSMETIC DAMAGE DUE TO WORN ETCH. IT WAS DETERMINED THAT THE MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY AND THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECKING FOR MECHANICAL FREE MOVEMENT, AND CHECKING GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. 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 14654963 ↗

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