DHS 338.22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982193261), received between Nov 21, 2022 and Apr 10, 2026 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break

  IT WAS REPORTED ON (B)(6), 2026 THAT THE AWL HAS BROKEN TIP, AND THE INSERTION INSTRUMENT WAS BENT. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839267 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE SURGERY, THE CONNECTING SCREW AND GUIDE SHAFT ATTACHED TO THE DHS IMPLANT, HOWEVER, THE WRENCH/T-HANDLE WOULD NOT FIT OVER THE COMPONENTS. THEREFORE, THERE WAS NO WAY TO DETERMINE THE ORIENTATION OF THE DHS SCREW, WHICH COULD AFFECT HOW THE PLATE FITS ONTO THE SCREW ONCE IN THE PATIENT. ANOTHER INSTRUMENT TRAY WAS OPENED TO FIND COMPONENTS AND T-HANDLE THAT WORKED PROPERLY, AND THESE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A SLIGHT DELAY TO OPEN ANOTHER TRAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DHS®/DCS® COUPLING SCREW-LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833963 ↗