DHS 281.131Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982176660), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT AN INITIAL SURGERY FOR IMPLANTATION OF A DYNAMIC HIP SYSTEM (DHS) INTO THE PROXIMAL FEMUR WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE LAG SCREW FOR THE DHS PLATE WAS PUT IN CORRECTLY, HOWEVER, THE PLATE WAS PUT IN OFF-AXIS. THEREFORE, THE PLATE HAD TO BE RE-POSITIONED, AND AS THE SURGEON WAS REMOVING THE CONNECTING SCREW AND GUIDE SHAFT FROM THE LAG SCREW, THE TWO INSTRUMENTS BECAME BENT (IT WAS REPORTED THAT THE SURGEON DID NOT DISCONNECT THE INSTRUMENTS PRIOR TO TAKING THEM OUT) AND THE SURGEON HAD TO USE PLIERS TO TAKE THE INSTRUMENTS OUT. THE SAME PLATE WAS PUT BACK INTO THE PATIENT WITHOUT ISSUE. A GUIDE WIRE WAS ALSO REPORTED TO BE BENT DURING THE SURGERY. THE PATIENT WAS IMPLANTED WITH A LAG SCREW, PLATE AND THREE 4.5 MM CORTICAL SCREWS (SIZE 36, 42 AND 48 MM). THERE WAS NO REPORTED DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT IN STERILE PROCESSING THE CONNECTING SCREW BROKE INTO TWO (2) PIECES AND THE GUIDE SHAFT, STILL IN ONE PIECE, WAS BENT TRYING TO GET THEM APART. THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE POST-OPERATIVE EVENT OF BROKEN/BENT (CONNECTING SCREW AND GUIDE SHAFT) INSTRUMENTS. CONCOMITANT DEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351462 ↗