DHHS 338.345Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982193407), received between Jan 3, 2017 and Aug 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025 THAT THERE WAS AN ISSUE WITH THE LCP DHHS COUPLING SCREW. THE THREADED TIP BROKE OFF DURING A REMOVAL SURGERY IN HARDWARE REMOVAL. PATIENT WAS REVISED TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22727956 ↗
• MalfunctionJul 24, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, THE LOCKING COMPRESSION PLATE (LCP) DYNAMIC HELICAL HIP SYSTEM (DHHS) CONNECTING SCREW BROKE WHILE SCREWING USING THE SPIRAL BLADE INSERTER. THERE WAS NO HARM TO THE PATIENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: SPIRAL BLADE INSERTER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1) . (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713341 ↗
• MalfunctionFeb 21, 2017Bent; Break; Bent; Break

  IT WAS REPORTED THAT WHILE INSPECTING FIELD EQUIPMENT, IT WAS NOTED THE TIP OF THE COUPLING SCREW WAS BENT. THE SYNTHES SALES CONSULTANT ATTEMPTED TO STRAIGHTEN THE TIP, CAUSING IT TO BREAK OFF. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6347742 ↗
• MalfunctionJan 3, 2017Break; Break

  IT WAS REPORTED THAT WHILE PUTTING A TRAY OF DEVICES BACK IN THE STERILE PROCESSING ROOM, THE LCP® DHHS(TM) COUPLING SCREW 324 MM WAS DISCOVERED TO BE DAMAGED. THE THREADS OF THE DEVICE WERE BROKEN OFF AT THE END OF THE COUPLING SCREW. THAT PIECE HAD BROKEN OFF AND WAS DISPOSED OF AT THE HOSPITAL. THERE WERE NO OTHER BROKEN PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LCP® DHHS(TM) COUPLING SCREW 324 MM. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6219285 ↗