NA 511.773Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982237804), received between Jan 12, 2018 and Jul 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT THERE IS RESIDUE IN THE TORQUE LIMITER (BLOOD). NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE TORQUE LIMITING ATTACHMENT 1.5NM/QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020142 ↗
• MalfunctionJan 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TORQUE LIMITER WAS FOUND LEAKING BROWN FLUID AFTER STERILIZATION. PATIENT INVOLVEMENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TORQUE LIMITING ATTACHMENT 1.5NM/QUICK COUPLING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192259 ↗
• MalfunctionJan 12, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING A TIBIAL PLATEAU LEVELLING OSTEOTOMY SURGICAL PROCEDURE ON AN UNSPECIFIED ANIMAL, IT WAS OBSERVED THAT THE TORQUE LIMITING DEVICE WAS NO LONGER MAKING A CLICKING NOISE AND HAD REACHED ITS UPPER LIMIT. THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS NOT AVAILABLE FOR USE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY SURGICAL PROCEDURE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186481 ↗