NA 2178-63-134Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10603295096238), received between Jul 21, 2017 and Aug 18, 2025 — classified as 137 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (53 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 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT THE HANDLE IS BROKEN POSSIBLY DUE TO OLD AGE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22829205 ↗
• MalfunctionJul 18, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THE SURGEON WAS ATTEMPTING TO TIGHTEN THE SLEEVE WHEN THE SLEEVE CLAMP CONTINUED TO SLIP AND LOSE GRIP. THIS DID NOT OCCUR DURING A PROCEDURE. AN ALTERNATIVE METHOD TO TIGHTEN SLEEVE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545761 ↗
• MalfunctionMay 19, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING A SURGERY WITH A SHORT-TERM-LOANER KIT, THE SURGEON FOUND THE REAMER TO BE BLUNT AND THE CLAMP JAMMED. THIS CAUSED A SURGERY PROLONGATION OF ABOUT 15 MINUTES. IN ADDITION, WHILE TRYING TO REMOVE THE BLUNT REAMER FROM THE MACHINE, THE SURGEON'S HAND WAS HIT BY THE MACHINE (NON-DEPUY PRODUCT), AND HE SUBSEQUENTLY COMPLAINED OF PAIN.

  Patient problems: Pain

  MAUDE report 22043579 ↗
• MalfunctionNov 13, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE UNIVERSAL ASSEMBLY HANDLE SEIZED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678386 ↗
• MalfunctionOct 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CLAMP IS BROKEN AS IT WOULDN¿T CLAMP THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 20513262 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE BROACH IS WARPED AND DOES NOT FIT ON HANDLE. THE METAL TIP BROKE OFF ON WRENCH. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20417710 ↗
• MalfunctionSep 26, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024 , DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE CLAMP WAS JAMMED AND THE 2 SUCTION INSERTERS WERE MISSING THEIR SUCTION CUP COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310800 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT THE HANDLE WAS BROKE AT THE END OF SURGERY DURING FINAL IMPLANT PREPARATION.

  Patient problems: Insufficient Information

  MAUDE report 19754974 ↗
• MalfunctionJun 11, 2024Mechanical Jam; Mechanical Jam

  THE HANDLE OF THE INSTRUMENT IS STUCK OR CANNOT BE PUSHED UP OR DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516171 ↗
• MalfunctionApr 9, 2024Structural Problem; Mechanical Jam; Structural Problem; Mechanical Jam

  THIS CLAMP WOULD LOCK WHEN WE WANTED TO CLOSE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070238 ↗
• MalfunctionFeb 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MECHANISM IN THE HANDLE IS DAMAGED. IT WOULD NOT GRIP ONTO THE SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788222 ↗
• MalfunctionJan 5, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL TIBIAL WRENCH IS WORN AND NO LONGER GRIPS IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451154 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE LOCKING MECHANISM HAS LOST ABILITY TO LOCK ON AND STAY LOCKED WHILE TIGHTENING SLEEVES. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691419 ↗
• MalfunctionAug 28, 2023Mechanical Jam; Mechanical Jam

  THE PRODUCT HANDLE GETS STUCK IN THE OPEN POSITION. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632490 ↗
• MalfunctionMay 25, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE IS WORN/BROKEN AFTER REPEATED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002305 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COUNTER TORQUE WRENCH DOESN'T HOLD THE IMPLANT SECURELY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223951 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COUNTER TORQUE WRENCH DOESN'T HOLD THE IMPLANT SECURELY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223894 ↗
• MalfunctionJan 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT ASSEMBLE AS INTENDED. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114382 ↗
• MalfunctionNov 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CLAMP IS LOCKED IN AN OPEN POSITION, DOES NOT TIGHTEN.

  Patient problems: Insufficient Information

  MAUDE report 15792478 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REVISION SLEEVE CLAMP DID NOT GRAB THE SLEEVE. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320237 ↗
• MalfunctionAug 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WRENCH WON¿T LOCK ONTO THE REVISION TIBIA TO TIGHTEN THE STEM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175123 ↗
• MalfunctionAug 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT STEM WRENCH WILL NOT GRAB THE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165276 ↗
• MalfunctionJun 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SLEEVE CLAMP BROKE. THE HAND ISN¿T CLAMPING. NO ADDED TIME TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676255 ↗
• MalfunctionMay 31, 2022Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT THE SLEEVE IS UNABLE TO CLAMP DOWN, DOESN¿T HOLD, LITTLE METAL ROD ON THE CLAMP BROKEN. NEW SET OPENED. 1 MINUTE DELAY TO SURGERY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547146 ↗
• MalfunctionMay 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CLAMP WAS NOT GRIPPING AS IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336457 ↗