DHS 338.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982193315), received between Oct 26, 2021 and Jan 13, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Break; Material Deformation

  IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059201 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DHS/DCS-WRENCH LOOKS TO BE SNAPPED OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308155 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A DHS REMOVAL CASE, THE SURGEON HAD A CHALLENGING TIME REMOVING THE LAG SCREW IMPLANT. THE INSERTION TOOL AS WELL AS THE CONNECTING SCREW WERE DAMAGED AND A PIECE OF THE CONNECTING SCREW BROKE OFF. SURGERY WAS DELAYED 15 MINUTES DUE TO THE REPORTED EVENT , HOWEVER WAS COMPLETED SUCCESSFULLY AND ALTHOUGH FRAGMENTS WERE GENERATED ALL PIECES ARE ACCOUNTED FOR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DHS/DCS ONE-STEP INSERTION WRENCH THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241445 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE INSTRUMENT IN QUESTION BROKE AS THE SURGEON ATTEMPTED TO REMOVE A DHS SCREW AND PLATE. PLIERS WERE USED TO REMOVE THE GENERATED FRAGMENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS®/DCS® ONE-STEP INSERTION WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18121004 ↗
• MalfunctionAug 2, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, OF A BROKEN TIP ON DHS REMOVAL HANDLE THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) DHS/DCS-WRENCH W/OCTAGONAL COUPL F/ONE-S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444542 ↗
• MalfunctionJul 19, 2023Break; Break

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 DURING A PLANNED REMOVAL OF A DHS, THE INCORRECT HANDLE WAS USED. THIS CAUSED THE HANDLE IN QUESTION TO BREAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DHS®/DCS® ONE-STEP INSERTION WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350932 ↗
• MalfunctionJan 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE LOAN SET WAS SENT TO THE CUSTOMER WITH CRITICAL INSTRUMENTS ALREADY DAMAGED AND UNUSABLE. THE CONNECTION SCREW INCLUDED IN THE DHS SET HAD BEEN BENT PRIOR TO ARRIVAL AT THE HOSPITAL AND COULD NOT BE PASSED THROUGH THE DHS WRENCH CANNULATION. AS A RESULT, THE SURGEON WAS UNABLE TO CONNECT THE DHS LAG SCREW TO THE INSERTER, NECESSITATING AN ALTERNATIVE TECHNIQUE TO COMPLETE THE OPERATION. THE SURGERY WAS DELAYED BY 120 MINUTES DUE TO THE REPORTED EVENT. THE SURGEON HAD TO INSERT THE DHS FREE HAND WITHOUT THE INSERTER DUE TO THERE BEING NO ALTERNATIVE INSTRUMENT AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DHS®/DCS® ONE-STEP INSERTION WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203294 ↗
• MalfunctionOct 26, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE DHS/DCS WRENCH BROKE WHILE INSERTING A SCREW INTO HARD BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DHS®/DCS® ONE-STEP INSERTION WRENCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699229 ↗