NA 393.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982199034), received between Mar 17, 2017 and Jun 9, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Difficult to Open or Close; Difficult to Open or Close

  THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THE PRODUCT WHEN TWISTED, DOESN'T CLOSE THE PRONGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167219 ↗
• MalfunctionSep 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE DEVICE WON'T STAY ASSEMBLED AND IS FALLING APART. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134285 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON 06-MARCH-2024 DURING INVENTORY CHECKS, IT WAS NOTICED THAT SOME INSTRUMENTS WERE NOT FUNCTIONING PROPERLY. THE END OF THE T25 SCREWDRIVER SHAFT WAS BENT AND COULD NOT CAPTURE SCREWS, AND THE RELEASE PORTION OF THE SMALL UNIVERSAL T-HANDLE CHUCK HAD DETACHED AND COULD NOT BE SCREWED BACK ON. NONE OF THESE INSTRUMENTS WERE USED OR DAMAGED DURING ANY CASES, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958069 ↗
• MalfunctionMar 13, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICES WERE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529031 ↗
• MalfunctionDec 15, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT BROKEN HANDLE SEEN DURING INVENTORY. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987423 ↗
• MalfunctionDec 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTER THE INNER PART OF THE DEVICE DROPPED OFF. THIS REPORT IS FOR A SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958446 ↗
• MalfunctionJun 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: UNABLE TO HOLD. ISSUE AN UNREPAIRABLE LETTER. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE UNIV-CHUCK SM W/T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694300 ↗
• MalfunctionAug 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE T-HANDLE CHUCK TOOTH IS NOT RETRACTING. THE DEVICE WORKED WELL IN THE CASE ON THE (B)(6) 2021. AFTER PROCESSING IT WAS DISCOVERED THAT THE TOOTH WAS BROKEN. THIS REPORT IS FOR A T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343675 ↗
• MalfunctionJul 8, 2021Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A CHUCK KEY WAS BROKEN. THIS REPORT IS FOR A SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134525 ↗
• MalfunctionJul 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TWO DEVICES WERE BROKEN DURING AN UNKNOWN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120654 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784365 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR 1 SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10225919 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10199684 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THE BROKEN SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS IDENTIFIED DURING AN UNKNOWN ORTHO CASE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY. THIS REPORT INVOLVES 1 SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10137369 ↗
• MalfunctionJun 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS UNABLE TO GRASP. THIS REPORT IS FOR ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118744 ↗
• MalfunctionFeb 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 ONE OF THE TEETH ON THE UNKNOWN T-HANDLE CHUCK WAS DISPLACED AND FELL OUT PRIOR TO THE CASE. IT WAS UNKNOWN IF THERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678071 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311716 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE OF THE TIPS OF THE SMALL UNIVERSAL CHUCK WITH T-HANDLE BROKE AND THE TIP WAS THROWN AWAY DURING CLEANING IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.  THIS REPORT IS FOR ONE (1) SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8684713 ↗
• MalfunctionSep 19, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INBOUND INSPECTION OF THE RETURNED LOANER KIT ON (B)(6) 2018, IT WAS OBSERVED THAT THE SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THE CHUCK HAS BEEN REMOVED FROM THE SET, PLACED IN QUARANTINE AND WILL BE RETURNED FOR EVALUATION. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SMALL UNIVERSAL CHUCK WITH T-HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7891087 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING ROUTINE INBOUND INSPECTION OF A RETURNED LOANER KIT, IT WAS OBSERVED THAT SMALL UNIVERSAL CHUCK WITH T-HANDLE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7877631 ↗
• MalfunctionMar 17, 2017Break; Break

  INCIDENT REGARDING FLEXIBLE SHAFT CONNECTOR IS CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6414204 ↗