DHHS 282.676Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982179371), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionJul 26, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY OF PROXIMAL FEMUR ON (B)(6) 2018, A LOCKING COMPRESSION (LCP) DYNAMIC HELICAL HIP SYSTEM (DHHS) PLATE - SHORT BARREL, JAMMED ONTO A DHHS HELIX BLADE WHILE INSERTING THE PLATE INTO THE HELIX BLADE. THE DHHS HELIX BLADE WAS INSERTED SUCCESSFULLY HOWEVER, THE PLATE WAS OFF ALIGNMENT ON INSERTION, WHICH ONLY ALLOWED PARTIAL INSERTION OVER THE HELIX BLADE. THE SURGEON USED A NON-SYNTHES MALLET/HAMMER AND DHHS IMPACTOR TO CONTINUE SEATING THE DHHS PLATE. THE DHHS PLATE ADVANCED SLIGHTLY AND THEN STOPPED. THE SURGEON CONTINUED MALLETING, WHICH RESULTED IN PUSHING THE HELIX BLADE FURTHER INTO THE FEMORAL HEAD. THE SURGEON STOPPED, FEARING THE BREACH OF FEMORAL HEAD INTO THE ACETABULAR JOINT. THE SURGEON USED A SOLID COUPLING SCREW FOR REMOVAL OF DHHS PLATE AND DHHS HELIX BLADE SIMULTANEOUSLY. ON THE BACK TABLE, THE SURGEON USED A NON-SYNTHES MALLET ON THE BACK OF THE COUPLING SCREW TO FORWARD SLAP AND DISENGAGE THE DHHS PLATE FROM HELIX BLADE. THE DHHS PLATE WAS NO LONGER USABLE DUE TO THE ROTATION COLLAR HAVING BEEN DEFORMED AND LOCKED ROTATION. THE DHHS HELIX BLADE WAS SALVAGED AND RE-INSERTED SUCCESSFULLY INT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7723124 ↗