Gauthier Biomedical 254600410Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00858325005169), received between Mar 16, 2020 and Jun 24, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLE IS NOT RATCHETING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323641 ↗
• MalfunctionJun 19, 2025Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  IT WAS REPORTED THAT DEVICES WEREN¿T TIGHTENING CORRECTLY AND ALSO STRIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292636 ↗
• MalfunctionFeb 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T-HANDLE WOULD NOT CONNECT THE 6MM HEX DRIVER. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379029 ↗
• MalfunctionFeb 6, 2025Calibration Problem; Unintended Movement; Calibration Problem; Unintended Movement

  IT WAS REPORTED THAT THE BROACH IS SPINNING ON THE FEMORAL TRIAL AFTER TORQUE OUT WHEN EXPLANTING.

  Patient problems: Insufficient Information

  MAUDE report 21327176 ↗
• MalfunctionAug 5, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE T-HANDLE BECAME LOOSE AND WILL NOT CHUCK ONTO SCREW DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908438 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT THE SPRING MECHANISM IN THE T HANDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018427 ↗
• MalfunctionFeb 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 'T' HANDLE TORQUE DRIVER FAILED TO TIGHTEN BROACH BOLT SUFFICIENTLY DURING A REVISION.

  Patient problems: Insufficient Information

  MAUDE report 18622531 ↗
• MalfunctionJan 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TORQUE LIMITING SCREWDRIVER FAILED TO TIGHTEN BROACH BOLT SUFFICIENTLY DURING THE REVISION. 3 ATTEMPTS WERE MADE. BOLT WAS TIGHTENED BY AN ALTERNATIVE METHOD. THIS INSTRUMENT WAS INSPECTED AFTER THE CASE AND PROBLEM COULD NOT DUPLICATED.

  Patient problems: Insufficient Information

  MAUDE report 18590255 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER ON T-HANDLE IS FALLING APART. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950272 ↗
• MalfunctionOct 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T HANDLE IS NOT HOLDING ATTACHMENTS CORRECTLY AND NOT TORQUEING RIGHT. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948797 ↗
• MalfunctionJun 7, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TORQUE LIMITER WAS NOT WORKING APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080329 ↗
• MalfunctionMar 6, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ATTUNE REVISION TORCH HANDLE WAS TORCHING WHEN TURNED TO THE LEFT WHEN IT SHOULD NOT BE. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486337 ↗
• MalfunctionMar 16, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE FEMORAL BROACH HANDLE WAS LOOSE AND WOULDN'T HOLD THE BROACHES AS SECURELY AS WOULD HAVE BEEN LIKED. THE T RATCHET HANDLE TORQUE LIMITER SEEMED BROKEN. THE 2 FEMORAL BROACH SCREWS WOULDN'T LOCK INTO FEMUR CORRECTLY. ALL INSTRUMENTS TAGGED BROKEN READY FOR RETURN. NO ADVERSE OUTCOME NOTED AS IN THE END CASE WENT WELL. SLIGHT EXTENSION OF CASE TIME BY 5 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9837782 ↗