NA 03.043.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10886982297372), received between Jul 1, 2021 and Mar 26, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 22, 2021Open, Classified

   Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.

   Z-0634-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 26, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE T HANDLE CHUCK IS BENT. IT CANNOT PASS A REAM ROD THROUGH IT. THERE WAS NO REPORTED PATIENT OR USER HARM WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698961 ↗
• MalfunctionJan 16, 2026Device Slipped; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ROD PUSHER WAS DEFORMED AT THE TIP, NOT ALLOWING IT TO BE SLID INTO THE BACK OF FLEXIBLE REAMER. T-HANDLE CHUCK WAS WORN AND WHEN TIGHTENED DOWN, DID NOT ADEQUATELY GRASP REAMING ROD. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094608 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT/ARE BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798594 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT/ARE BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798592 ↗
• MalfunctionAug 13, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT/ARE BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798591 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WORN PRODUCTS THAT DON¿T CONNECT, DON¿T TIGHTEN AND ARE UNABLE TO CONNECT / ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790304 ↗
• MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INTRAMEDULLARY FEMORAL NAILING PROCEDURE, THE T HANDLE CHUCK LOCKED UP AROUND A 2.5MM BALL TIP GUIDE WIRE, AND THE SURGEON WAS UNABLE TO TIGHTEN OR UNTIGHTEN THE T HANDLE CHUCK. ALTERNATE INSTRUMENTATION WAS UTILIZED TO CONTINUE THE PROCEDURE. IN STERILE PROCESSING AFTER WASHING THE PROBLEM INSTRUMENTS, STAFF WAS UNABLE TO GET THE INSTRUMENT TO UNLOCK OR LOCK CORRECTLY, INDICATING A DEFECTIVE TIGHTENING MECHANISM. THE FACILITY DISPOSED OF THE FAULTY T-HANDLE CHUCK INSTRUMENT. THERE WAS 5 MIN SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22474020 ↗
• MalfunctionMay 20, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT A T HANDLE CHUCK WAS BROKEN. THE LOCKING MECHANISM HAS STOPPED WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053022 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE T HANDLE CHUCK WAS FOUND TO BE BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874392 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272827 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268243 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268170 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268154 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268141 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE 2.5MM BALL TIP GUIDE WIRE BECAME LODGED IN THE NAIL AND WAS NOT ABLE TO BE REMOVED. THE NAIL WAS REMOVED TO SEE THAT THE POLYMER HAS MIGRATED UP THE NAIL AND CAUSED IT TO BIND UP IN THE CANNULATION. BOTH THE T-HANDLE CHUCK AND IMPACTION TOOL WERE DAMAGED AND BROKEN INTO MULTIPLE PIECES DURING THE REMOVAL PROCESS. THE NAIL WAS REMOVED AND AN ALTERNATE NAIL WAS OPENED TO PROCEED ON WITH THE SURGERY. NO HARM WAS DONE TO THE PATIENT AND SURGICAL TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924964 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439785 ↗
• MalfunctionSep 17, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE DOES NOT OPEN OR CLOSE. THEY HAD TO OPEN AN OLD UNIVERSAL CHUCK FOR CASE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238999 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS FURTHER REPORTED THAT THE INCIDENT OCCURRED POSTOPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 20205022 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE UNIVERSAL CHUCK GOT STUCK DURING A RETROGRADE NAIL SURGERY. SIMILAR ISSUES HAVE HAPPENED IN THE PAST. THE SURGEON WAS NOT ABLE TO GET IT OFF THE REAMING ROD DURING SURGERY AND HAD TO TAKE OUT THE REAMING ROD. IT WAS DIFFICULT TO GET THE REAMING ROD PAST THE FRACTURE THE FIRST TIME AS WELL AS THE SECOND TIME. THERE WAS A FIVE-MINUTE DELAY WHILE A NEW TRAY WAS BROUGHT FROM THE STERILE PROCESSING DEPARTMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE UNIVERSAL CHUCK THIS IS REPORT 1 OF 1 FOR (B)(4) . THIS REPORT IS RELATED TO (B)(4) . THIS REPORT CAPTURES THE EVENT THAT OCCURRED ON (B)(6), 2024. (B)(4) CAPTURES THE EVENTS THAT HAPPENED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808259 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AN UNKNOWN DATE, THE UNIVERSAL CHUCK GOT STUCK DURING A RETROGRADE NAIL SURGERY. THE SURGEON WAS NOT ABLE TO GET IT OFF THE REAMING ROD DURING SURGERY. THIS REPORT INVOLVES ONE UNIVERSAL CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) . THIS REPORT CAPTURES THE SIMILAR EVENTS THAT WERE REPORTED TO HAVE HAPPENED IN THE PAST. (B)(4) CAPTURES THE EVENT THAT OCCURRED ON JUNE 29, 2024.

  Patient problems: Insufficient Information

  MAUDE report 19808106 ↗
• MalfunctionSep 18, 2023Break; Break

  THE INITIAL COMPLAINT WAS REVIEWED, AND THE UNIVERSAL CHUCK WAS DETERMINED TO BE NOT REPORTABLE. THIS WAS IDENTIFIED TO BE A DUPLICATE OF THE PRODUCT REPORTED IN MWR# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765166 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO INSTRUMENTS FAILED DURING A TIBIAL NAIL CASE. A SECOND ANS SET WAS AVAILABLE, SO INSTRUMENTS FORM THAT SET WERE UTILIZED. THE FIRST INSTRUMENT WAS THE UNIVERSAL T HANDLE CHUCK, WHICH SEEMED TO BE BROKEN INTERNALLY AND WOULD NOT OPERATE CORRECTLY. THE DRIVING CAP ALSO CAME APART DURING THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE UNIVERSAL CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391481 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE T HANDLE BROKE APART DURING A SURGICAL CASE. BALL BEARINGS FELL OUT OF THE DEVICE ON THE BACK TABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE UNIVERSAL CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388365 ↗
• MalfunctionMay 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T HANDLE CHUCK SIZE IS NOT ADJUSTING. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT INVOLVES ONE (1) UNIVERSAL CHUCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885786 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 HAD A SHANZ PIN GET STUCK AND UNABLE TO RELEASE, HOSPITAL DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL CHUCK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487281 ↗