NA 05.001.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982129970), received between Jun 18, 2021 and Apr 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE MODIFIED TRINKLE DRILL ATCH FOR TRS DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD COSMETIC DAMAGE, WAS FROZEN/WOULD NOT MOVE AND THE LABELING / ETCHING WAS ILLEGIBLE. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION, MARKING AND LABELING, CHECK FOR MECHANICAL FREE MOVEMENT AND CHECK GENERAL FUNCTION IN RUNNING MODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929691 ↗
• MalfunctionFeb 18, 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 ATTACHMENT DEVICE HAD COSMETIC DAMAGE, WAS FROZEN/WILL NOT MOVE, MECHANICS SEIZED, AND WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS NOTED THAT THE MARKING LABEL PEELED OFF, THE TOOL CONNECTION WAS GETTING CAUGHT, THE SLEEVE PIN WAS LONG, THE SHAFT DID NOT MOVE, AND DID NOT WORK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, CHECK THE TOOL COUPLING, 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 DID NOT WORK. WHEN SET ON THE MAIN BODY, BUT IT DID NOT WORK, BUT OTHER ATTACHMENTS WORKED. 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 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 21402208 ↗
• MalfunctionJul 15, 2024Mechanical 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 DRILL ATTACHMENT DEVICE HAD THE FOLLOWING FAILURES: FROZEN/WILL NOT MOVE, DOES NOT FUNCTION AND MOVING PARTS DO NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ON THE FOLLOWING: 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 BUT WAS NOTED TO HAVE OCCURRED IN 2024. 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 19740851 ↗
• MalfunctionApr 25, 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 MODIFIED TRINKLE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE DUE TO WORN ETCH, COLOR BAND CHIPPING/FADING, SEIZED MECHANICS, AND ILLEGIBLE. IT WAS DETERMINED THAT THE DEVICE WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECKING THE TOOL COUPLING, CHECKING PINS LENGTH OF HANDPIECE COUPLING, 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 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 16804489 ↗
• MalfunctionApr 21, 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 ATTACHMENT DEVICE HAD SEIZED UP, WAS FROZEN/WILL NOT MOVE, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK FOR MECHANICAL FREE MOVEMENT, AND CHECK GENERAL FUNCTION IN RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS FAULTY. 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 16785697 ↗
• MalfunctionOct 26, 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 DRILL ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD SEIZED AND CORRODED BEARING, AND SEIZED GEAR. 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. 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 15672033 ↗
• MalfunctionJun 23, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT THE MODIFIED TRINKLE DRILL ATTACHMENT DEVICE WOULD 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 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 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 12053242 ↗
• MalfunctionJun 18, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT THE DRILL ATTACHMENT DEVICE DID NOT WORK WHEN CONNECTED TO THE HANDPIECE DEVICE. IT WAS REPORTED THAT AFTER THE DEVICE WAS CONNECTED AND REMOVED FOR ABOUT FOUR TIMES, THE DEVICE WORKED. 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 12024249 ↗