DHS 338.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982193155), received between Aug 10, 2018 and Apr 6, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Failure to Cut

  IT WAS REPORTED THAT THE REAMER AND BARREL REAMERS WERE DULL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793589 ↗
• MalfunctionApr 6, 2026Failure to Cut

  IT WAS REPORTED THAT THE REAMER AND BARREL REAMERS WERE DULL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793587 ↗
• MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672974 ↗
• MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672969 ↗
• MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672967 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, STAFF WAS DOING A CORE HIP DECOMPRESSION. DRILL BIT BROKE INSIDE PATIENT, MINIMAL DELAY. REMOVED DRILL/PIECES CONTINUED WITH COMPETITOR SYSTEM. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832309 ↗
• MalfunctionAug 19, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON 07-JULY-2022, THE FOLLOWING PRODUCT ISSUES WERE DISCOVERED. BOTH THE STANDARD LENGTH AND SHORT DHS REAMING HEADS WERE FOUND TO BE DULL. THE 8MM DRILL BIT FOR THE REAMER WAS ALSO FOUND TO BE DULL. THE DHS IMPACTOR WAS FOUND TO HAVE FRACTURED AT THE TIP. THIS REPORT IS FOR AN 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261052 ↗
• MalfunctionAug 10, 2018Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(4): IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE STEP DRILL BITS FROM THE THREE DYNAMIC HIP SCREW (DHS) SET WERE UNABLE TO CUT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7771928 ↗
• MalfunctionAug 10, 2018Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(4): IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE STEP DRILL BITS FROM THE THREE DYNAMIC HIP SCREW (DHS) SET WERE UNABLE TO CUT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7771924 ↗
• MalfunctionAug 10, 2018Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES(B)(4): IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE STEP DRILL BITS FROM THE THREE DYNAMIC HIP SCREW (DHS) SET WERE UNABLE TO CUT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7771919 ↗