DHS 338.06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982193131), received between Dec 19, 2017 and Feb 25, 2020 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING THE REMOVAL OF SCREWS, THE DYNAMIC HIP SCREW (DHS) WRENCH T END BROKE OFF. THE SURGEON USED THE OTHER T END AND GOT THE UNKNOWN LAG SCREW OUT SUCCESSFULLY. THERE WERE ALSO TWO (2) BROKEN UNKNOWN CORTEX SCREWS WHICH WERE REMOVED SUCCESSFULLY FROM THE PLATE USING THE SCREW REMOVAL SET. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE DHS/DCS-WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749720 ↗
• 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 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7360157 ↗
• MalfunctionDec 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A HIP FRACTURE REPAIR PERFORMED ON (B)(6) 2017. THE "T" PORTION OF THE DHS/DCS (DYNAMIC HIP SCREW/DYNAMIC COMPRESSION SCREW) WRENCH WAS NOTED TO BE EXHIBITING UNDESIRED MOVEMENT AND APPEARED AS THOUGH IT WERE ABOUT TO BREAK OFF. SECONDLY, THE DHS/DCS GUIDE SHAFT WITH FLATS WAS BENT DURING THE SURGERY AND WOULD NOT ENGAGE THE LAG SCREW AS EXPECTED. LASTLY, THE DHS/DCS COUPLING SCREW WAS ALSO NOTED TO BE BENT AND WOULD NOT GO THROUGH THE DHS/DCS GUIDE SHAFT WITH FLATS TO PROPERLY ENGAGE THE LAG SCREW. THE REPORTER WILL PROVIDE ADDITIONAL INFORMATION CONCERNING ANY SURGICAL DELAYS, THE DEVICES USED TO COMPLETE THE SURGERY, ANY CONCOMITANT DEVICE USED, PATIENT INFORMATION, WHETHER ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AND THE STATUS OF THE PATIENT AT THE END OF THE PROCEDURE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: LAG SCREW (PART UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS IS REPORT 3 OF 3 FOR (B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130156 ↗