DHS 280.295Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982175175), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN PROCEDURE WAS PERFORMED, RIA 2 WAS USED WITH REAMER HEAD AND THE TUBING SCRUNCHED UP DUE TO EXCESSIVE FORCE. THE REAMER HEAD BROKE. ON THE IPSILATERAL SIDE A DYNAMIC HIP SYSTEM (DHS) WAS INSERTED BUT THE LAG SCREW WAS RIPPED DURING INSERTION. ON THE CONTRALATERAL SIDE TWO DISTAL FIBULA PLATES ENDED UP CROSS THREADING THE VARIABLE ANGLE (VA) LOCKING HOLES. THERE WAS A SURGICAL DELAY OF 10 MINUTES. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART NUMBER 03.404.000S, LOT UNKNOWN, QUANTITY 1). 10.0MM REAMER HEAD FOR RIA 2 STERILE (PART NUMBER 03.404.016S, LOT UNKNOWN, QUANTITY 1). 2.0MM THRDD GUIDE F/ 2.7MM SCR VA AND LCP (PART NUMBER 03.133.008, LOT UNKNOWN, QUANTITY 1). 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT (PART NUMBER 02.118.408, LOT UNKNOWN, QUANTITY 1). 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT (PART NUMBER 02.118.405, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/95MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272389 ↗