DHS 280.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982174895), received between Sep 20, 2019 and Sep 20, 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.

• MalfunctionSep 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, A DYNAMIC HIP AND CONDYLAR SCREW (DHS/DCS) COUPLING SCREW WOULD NOT THREAD ONTO THE LAG SCREW. IT WAS DISCOVERED TO HAVE BROKEN THREADS. A NEW CONNECTING SCREW WAS SELECTED FROM THE SET AND WAS USED BUT IT WOULD NOT THREAD ONTO THE DYNAMIC HIP AND CONDYLAR SCREW (DHS/DCS) LAG SCREW. IT WAS DISCOVERED THAT THE DHS/DCS LAG SCREW HAD AN INTERNAL BLEMISH PREVENTING THE THREADING. A SECOND DHS IMPLANT SET WAS OPENED FOR A NEW DHS/DCS LAG SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNK - INSERTION INSTRUMENTS: CONNECTING / COUPLING SCREW: TRAUMA (PART # / LOT # /QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HS®/DCS® LAG SCREW 12.7 MM THREAD/105 MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100872 ↗