DHS 338.08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982193148), received between Jun 21, 2019 and Sep 26, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DHS 130 DEGREE GUIDE AND T HANDLE WERE USED DURING A PROCEDURE. THE GUIDE KEPT DISENGAGING. WHILE INSERTING THE CSS+ LARGE SCREW, THE HANDLE QUIT RATCHETING AND BOTH SCREWDRIVER HEADS WERE STRIPPED. THE SCREW WAS INSERTED AND THE HEAD SNAPPED OFF DUE TO TORQUE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DHS®/DCS® T-HANDLE QC. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818759 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY IT WAS NOTICED THAT THE T-HANDLE FOR QUICK COUPLING WOULD NOT DISENGAGE FROM THE ANGLED GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A T-HANDLE FOR QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559254 ↗
• MalfunctionFeb 25, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH DHS T-HANDLES WOULD NOT HOLD THE INSTRUMENTS AND THE SPRING MECHANISMS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DHS®/DCS T-HANDLE QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377727 ↗
• MalfunctionFeb 25, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH DHS T-HANDLES WOULD NOT HOLD THE INSTRUMENTS AND THE SPRING MECHANISMS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DHS®/DCS T-HANDLE QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377716 ↗
• MalfunctionJun 21, 2019Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HIP SURGERY. DURING THE SURGERY, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) T-HANDLE DID NOT CONNECT AND WAS IMPOSSIBLE TO CLEAN PROPERLY, AND A PINNACLE STRAIGHT CUP IMPACTOR BROKE INTO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DHS®/DCS® T-HANDLE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8721870 ↗