DHHS 282.240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982178299), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR USING A DYNAMIC HELICAL HIP SYSTEM (DHHS). THE HELICAL/HELIX BLADE WAS INSERTED IN A NORMAL FASHION. AS THE SURGEON WENT TO KEY IN THE HELICAL BLADE, THE HELICAL BLADE OVER-INSERTED. WHEN THE SURGEON TRIED TO BACK UP THE HELICAL BLADE, IT WOULD NOT SLIDE THROUGH THE PLATE/SIDE PLATES STANDARD BARREL. THE HELICAL BLADE AND THE PLATE WERE REMOVED IN A SINGLE PIECE AND A NEW HELICAL BLADE AND PLATE WERE REINSERTED WITHOUT INCIDENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9377445 ↗