DHS 338.19Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982193216), received between Mar 21, 2018 and Apr 1, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON MARCH 14, 2024, THAT THE ITEM IS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS/DCS CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011257 ↗
• MalfunctionDec 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INNER SLEEVE BECOMES STUCK AGAINST THE T HANDLE. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) DHS/DCS CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345444 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153449 ↗
• MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153448 ↗
• MalfunctionFeb 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSPECTING INSTRUMENTS IN STERILE PROCESSING, IT WAS NOTICED THAT A COUPLE OF INSTRUMENTS WERE DAMAGED. IT WAS INFORMED THE SPD MANAGER AND HE STATED HE WOULD REPLACE THESE DAMAGED INSTRUMENTS. NO PATIENT CONSEQUENCE WAS REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DHS/DCS CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340163 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A DYNAMIC HIP SCREW (DHS) PROCEDURE ON (B)(6) 2021, DHS/DCS® CENTERING SLEEVE, LONG AND DHS/DCS-WRENCH DID NOT ASSEMBLE PROPERLY. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DHS®/DCS® CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316585 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EQUIPMENT ASSEMBLY IN STERILE PROCESSING, IT WAS DISCOVERED THAT THE DHS/DCS WRENCH WAS STICKING WITH INTERFACE OF DHS/DCS CENTERING SLEEVE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS®/DCS® CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078142 ↗
• MalfunctionOct 30, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) CENTERING SLEEVE WAS FOUND NOT FUNCTIONING DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DHS®/DCS® CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9254217 ↗
• MalfunctionJul 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DYNAMIC HIP SCREW (DHS) CENTERING SLEEVE LONG AND DHS WRENCH WOULD NOT FIT TOGETHER. THERE WAS SOME DAMAGE ON EITHER THE CENTERING SLEEVE OR THE WRENCH. IT WAS DISCOVERED WHEN PUTTING THE TRAY BACK TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DHS®/DCS® CENTERING SLEEVE LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8780396 ↗
• MalfunctionJul 21, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 IT WAS NOTED THAT THE INSIDE OF A DYNAMIC HIP AND CONDYLAR SCREW CENTERING SLEEVE WAS FLAKING OFF COLORED PIECES IN THE WASHING PHASE OF DECONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7708520 ↗
• InjuryMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A UNKNOWN PROCEDURE ON (B)(6) 2018, WHILE THE SURGEON WAS USING THE DHS®/DCS® WRENCH, FOR INSERTING A DHS®/DCS® COUPLING SCREW, UPON INSERTION INTO THE FEMORAL HEAD, THE DHS®/DCS® WRENCH WOULD NOT DISCONNECT AND SLIDE OFF FROM GUIDE SHAFT ASSEMBLY (DHS®/DCS® CENTERING SLEEVE AND DHS®/DCS® GUIDE SHAFT). DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM (PART # 280.950, LOT # 5522496, QTY # 1) WAS ATTACHED TO THE GUIDE SHAFT AND COUPLING SCREW AND WAS NOT ABLE TO DETACH BECAUSE IT WAS STUCK INSIDE OF THE WRENCH. UPON TRYING TO DISCONNECT IT, THE HANDLE BROKE OFF THE DHS WRENCH. THE DHS®/DCS® COUPLING SCREW AND THE GUIDE SHAFT ASSEMBLY WERE REMOVED BY MOVING BACK AND FORTH. THERE WAS A SURGICAL DELAY OF 8-10 MINUTES. THE SURGERY WAS COMPLETED USING THE DYNAMIC HELICAL HIP SYSTEM (DHHS). THE PATIENT WAS UNHARMED. CONCOMITANT DEVICES REPORTED: DHS®/DCS® COUPLING SCREW (PART # 338.20, LOT # UNKNOWN, QTY #1). THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7360166 ↗