DHHS 282.610SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982178671), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

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

• MalfunctionJan 19, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2017, THE DYNAMIC HELICAL HIP SYSTEM (DHHS) HELICAL BLADE HAD BEEN IMPLANTED AND THE SURGEON WAS IN THE PROCESS OF SLIDING THE SIDE PLATE OVER THE BACK OF THE HELICAL BLADE. THEY STARTED USING THE IMPACTOR TO ADVANCE THE SIDE PLATE AND AFTER 5-6 HITS IT WAS NOTED RADIOGRAPHICALLY THAT THE HELICAL BLADE WAS ADVANCING. AFTER TRYING TO REMOVE THE SIDE PLATE FOR 4-5 MIN THE SIDE PLATE AND THE HELICAL BLADE CAME OUT AS ONE UNIT. THE BARREL OF THE SIDE PLATE BECAME LODGED ON THE HELICAL BLADE. A NEW HELICAL BLADE AND SIDE PLATE WERE THEN IMPLANTED AND THE CASE WAS FINISHED SUCCESSFULLY. THIS EVENT CAUSED A 15 TO 20-MINUTE DELAY IN SURGERY. NO ADDITIONAL X-RAYS AVAILABLE. THE PATIENT OUTCOME WAS NOTED AS STABLE. THIS REPORT IS FOR ONE (1) 135 DEGREE LCP DHHS SIDEPLATE-STANDARD BARREL THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7208163 ↗