NA 311.44Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982187413), received between Mar 24, 2017 and Jan 20, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED DURING ROUTINE MEDICAL DEVICE CLEANING, STAFF NOTICED THAT THE QUICK COUPLING MECHANISM NO LONGER RETRACTS IN ORDER TO CONNECT TO INTENDED SHAFT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118051 ↗
• MalfunctionJul 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP). ALL ITEMS WERE NOTICED PRE-OP BEFORE A PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394524 ↗
• MalfunctionSep 11, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-HANDLE WITH QUICK COUPLING IS BENT AND CHIPPED AND STRUGGLES TO MOTE AT TIMES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190119 ↗
• MalfunctionMay 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION IN STERILE PROCESSING ON APRIL 14, 2024, THAT ITEMS ARE STUCK TOGETHER AND THEY ARE NOT ABLE TO SEPARATE THEM. UNKNOWN HOW THE ITEMS BECAME STUCK. IT APPEARS AS THOUGH THE CONICAL EXTRACTOR BECAME LODGED IN THE T-HANDLE BEARINGS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270910 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED THAT ON 19-JANUARY-2024 DURING STERILE PROCESSING, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN. BOTH PRODUCTS HAVE BROKEN LOCKING MECHANISMS IN THE HANDLE. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630275 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO INSTRUMENTS WERE DISCOVERED TO BE BROKEN. 311.44 WAS FOUND WITH THE BEARINGS BROKEN IN THE LATCH PORTION OF THE T HANDLE. 399.680 WAS FOUND WITH A BROKEN TIP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906480 ↗
• MalfunctionFeb 24, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE T-HANDLE WAS FOUND BROKEN IN STERILE PROCESSING. THE COUPLING IS STUCK, SO NOTHING CAN BE ATTACHED TO THE HANDLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435348 ↗
• MalfunctionNov 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE QUICK COUPLING MECHANISM WAS NO LONGER ENGAGING. THIS WAS DISCOVERED BY THE MEDICAL DEVICE REPROCESSING DEPARTMENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868812 ↗
• MalfunctionNov 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE QUICK COUPLING MECHANISM WAS NO LONGER ENGAGING. THIS WAS DISCOVERED BY THE MEDICAL DEVICE REPROCESSING DEPARTMENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868811 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING A HARDWARE REMOVAL CASE, A T8 DRIVER BECAME STUCK IN A T-HANDLE QUICK CONNECT. THE T8 WAS NEVER ABLE TO BE REMOVED. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. NO ADVERSE EVENTS OCCURRED RELATED TO THE SCREWDRIVER. NO PATIENT INTERACTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829416 ↗
• MalfunctionJun 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842156 ↗
• MalfunctionJun 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842131 ↗
• MalfunctionMay 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, DURING A MATERIAL EXTRACTION SURGERY, SEVERAL PIECES OF THE EXTRACTION SET WERE DAMAGED DURING THE TRANSOPERATIVE PERIOD. TWO PIECES OF REVERSE THREADS WERE BROKEN ON THE EXTRACTION SCREWS. A T-HANDLE WAS BENT. IN ADDITION, A TREPHINE WAS BROKEN TRYING TO DRILL BONE TO REMOVE THE SCREW. IT SHOULD BE NOTED THAT NONE OF THE PIECES THAT BROKE REMAINED INSIDE THE PATIENT AND THE SCREWS COULD BE REMOVED AFTER MUCH EFFORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIXTY (60) MINUTE DELAY AND NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A T-HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433949 ↗
• MalfunctionMay 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) REDUCTION FORCEP POINTS RACHET, PROTECTION SLEEVE, TROCAR, SHARP HOOK, INSERTION GUIDE, TWO (2) T-HANDLE WITH QUICK COUPLING, SCREWDRIVER SHAFT, DRIVING CAP AND RADIOLUCENT INSERTION HANDLE WERE FOUND DAMAGED AFTER USE IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345635 ↗
• MalfunctionMay 10, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO REDUCTION FORCEP POINTS RACHET, PROTECTION SLEEVE, TROCAR, SHARP HOOK, INSERTION GUIDE, TWO (2) T-HANDLE WITH QUICK COUPLING, SCREWDRIVER SHAFT, DRIVING CAP AND RADIOLUCENT INSERTION HANDLE WERE FOUND DAMAGED AFTER USE IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345503 ↗
• MalfunctionMay 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION OF BACK UP INSTRUMENTS ON AN UNKNOWN DATE, THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAD A LOOSE NEEDLE, TWO HANDLE WITH MINI QUICK COUPLING HAD ISSUES LOCKING DRIVER SHAFT, TWO HOLD-SL Ø2 F/COMPRESSION/DISTRACTION DEV DID NOT LOCK WIRES, COMPRESSION/DISTRACTION INSTRUMENT TURN KNOB KEPT POPPING OFF, COMP/DISTRACTION INSTR FOR ULNA OSTEO HAD A WIRE STUCK INSIDE THE DEVICE, AND A T-HANDLE WITH QUICK COUPLING HAD A CONICAL EXTRACTION SCREW STUCK INSIDE. THERE WAS NO HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289148 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE COUPLING T-HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587977 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543754 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS BROKE DUE TO USAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543692 ↗
• MalfunctionFeb 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A NURSING STAFF INDICATED THAT A CONICAL SCREW COULD NOT BE DISENGAGED FROM A T-HANDLE WITH QUICK COUPLING. ADDITIONALLY QUICK COUPLING ON A HANDLE WITH QUICK COUPLING, SMALL APPEARS TO BE FUSED AND WILL THEREFORE NO LONGER ENGAGE DRIVE COMPONENTS. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) T-HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501731 ↗
• MalfunctionNov 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SCREWDRIVER SHAFT AND T-HANDLE ARE JAMMED ONE INTO THE OTHER AND CANNOT BE DISASSEMBLED. THERE WAS A TWO (2) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A REPLACEMENT SCREWDRIVER. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728214 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER WAS BROKEN. IT IS UNKNOWN HOW THE ISSUE OCCURRED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414173 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING STERILIZATION A SCREWDRIVER SHAFT WAS STUCK ON THE T-HANDLE SCREWDRIVER. UPON CHECKING, THE SCREWDRIVER SHAFT WAS COMPLETELY FROZEN ON THE HANDLE. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) T-HANDLE WITH QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288161 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOLLOWING PRODUCT WAS FOUND BROKEN: ALUMINUM CASE, DEPTH GAUGE, T-HANDLE WITH QUICK COUPLING, TWO CANNULATED HEXAGONAL SCREWDRIVER, AND HEXAGONAL SCREWDRIVER. ATTACHED TO CANNULATED POWER SHAFT IS A LARGE QUICK COUPLING THAT NEEDS TO REPAIR. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES (6) DEVICES. THIS REPORT IS FOR (1) T-HANDLE WITH QUICK COUPLING. THIS REPORT IS 2 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260679 ↗
• MalfunctionJul 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A LEAD SPD TECHNICIAN GAVE A PEEL OF PACK DEFECTIVE INSTRUMENTS. FOUR T8 STAR-DRIVE, ONE T-HANDLE WITH QUICK CONNECT, AND ONE 2.0/2.4 DEPTH GAUGE. THREE OF THE T8 STAR-DRIVE ARE TWISTED, ON E STAR-DRIVE AND THE T-HANDLE WILL NOT COME APART, AND THE DEPTH GAUGE IS BROKEN. IT WAS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT WAS UNKNOWN OF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) T-HANDLE WITH QUICK COUPLING. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121658 ↗