DHS 338.20Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886982193223), received between Feb 13, 2017 and Mar 10, 2026 — classified as 4 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DHS SCREW INSERTER WAS BENT SO IT DID NOT CAPTURE THE SCREW. THEREFORE IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558348 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DHS SCREW INSERTER WAS BENT SO IT DID NOT CAPTURE THE SCREW. THEREFORE IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558347 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE COUPLING SCREW TIP BROKE INTRAOPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO FRAGMENTS WERE GENERATED, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280772 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE TIP OF THE SCREWDRIVER BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583568 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED SEVERAL INSTRUMENTS WERE BROKEN: 03.045.004 SHORT RETENTION PIN (THREAD HAS BROKEN). 338.200 DHS CONNECTING SCREW (THREAD HAS BROKEN). 03.037.028 SCREWDRIVER HEX FLEX (SHAFT SNAPPED OFF FROM THE HANDLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905217 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COUPLING SCREW FOR THE DHS BROKE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855905 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM BROKE DURING THE MIDDLE OF A CASE AND DOCTORS WEREN¿T ABLE TO USE IT DURING THE CASE. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. DOCTORS OPENED A NEW SET. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED OR NOT. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352870 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE A COUPLING SCREW FOR DHS WAS BROKEN. WHILE INSERTING THE COUPLING SCREW, IT BROKE OFF IN LAG SCREW. THIS REPORT IS FOR A DHS/DCS COUPLING SCREW.

  Patient problems: Insufficient Information

  MAUDE report 20146755 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT ON APR 25, 2024 DURING INSERTION OF A DHS LAG SCREW THE DHS GUIDE SHAFT AND CONNECTING SCREW BROKE AND DAMAGED THE END OF THE LAG SCREW TO WHERE THE PLATE COULD NOT SLIDE OVER THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED BY ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19382405 ↗
• MalfunctionAug 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6), 2023, THAT THE INSTRUMENT BROKE AT THE TOP OF IT X 2 MISSING SPRING FOR HOLDING SLEEVE. THERE WAS NO SURGICAL DELAY DUE TO THE RELATED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1DHS/DCS COUPLING SCREW. THIS IS REPORT 4 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451891 ↗
• MalfunctionAug 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INSTRUMENT BROKE AT THE TOP OF IT X 2 MISSING SPRING FOR HOLDING SLEEVE. THERE WAS NO SURGICAL DELAY DUE TO THE RELATED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 1 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451717 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE SURGERY, THE CONNECTING SCREW AND GUIDE SHAFT ATTACHED TO THE DHS IMPLANT, HOWEVER, THE WRENCH/T-HANDLE WOULD NOT FIT OVER THE COMPONENTS. THEREFORE, THERE WAS NO WAY TO DETERMINE THE ORIENTATION OF THE DHS SCREW, WHICH COULD AFFECT HOW THE PLATE FITS ONTO THE SCREW ONCE IN THE PATIENT. ANOTHER INSTRUMENT TRAY WAS OPENED TO FIND COMPONENTS AND T-HANDLE THAT WORKED PROPERLY, AND THESE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A SLIGHT DELAY TO OPEN ANOTHER TRAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833956 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENT BROKE INSIDE THE LAG SCREW INSERTION. THERE WAS A SURGICAL DELAY FOR ABOUT TWO (2) HOURS. THE IMPLANT AND ANOTHER INSTRUMENT NEEDED TO BE STERILIZED. THE IMPLANT WAS REMOVED AND NEW IMPLANTS WERE INSERTED WITH DIFFERENT INSTRUMENTS AND SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289085 ↗
• MalfunctionDec 20, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN, THE INSERTION SCREWDRIVER PIECES ARE BENT CAUSING THEM TO NOT PROPERLY FIT IN THE INSERTION HANDLE. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) DHS/DCS COUPLING SCREW THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048725 ↗
• MalfunctionDec 20, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN, THE INSERTION SCREWDRIVER PIECES ARE BENT CAUSING THEM TO NOT PROPERLY FIT IN THE INSERTION HANDLE. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) DHS/DCS COUPLING SCREW. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048721 ↗
• MalfunctionNov 12, 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 COUPLING SCREW, IMPACTOR TIP, AND LAG SCREW BROKE. NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804162 ↗
• MalfunctionSep 21, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE APPLICATION OF A DYNAMIC HIP SYSTEM (DHS) FOR AN INTERTROCHANTERIC FRACTURE THE DHS COUPLING SCREW BROKE ALONG WITH THE TWO (2) TIP FOR DHS IMPACTOR. IT WAS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. ANOTHER SET WAS OPENED, AND THE ITEMS WERE PULLED FROM THE SECOND SET. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: TIP FOR DHS®/DCS® IMPACTOR (PART NUMBER 338.26, LOT 6043333, QUANTITY 1), TIP FOR DHS®/DCS® IMPACTOR (PART NUMBER 338.26, LOT H479753, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560263 ↗
• MalfunctionApr 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COUPLING SCREW WAS BROKEN IN DYNAMIC HIP SYSTEM (DHS) SET DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 DHS/DCS COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9996751 ↗
• MalfunctionApr 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COUPLING SCREW WAS BROKEN IN DYNAMIC HIP SYSTEM (DHS) SET DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 1 DHS/DCS COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9996627 ↗
• MalfunctionMar 30, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE NURSE WAS ATTEMPTING TO SCREW THE COUPLING SCREW FOR INSERTION INTO THE LAG SCREW AND IT WOULD NOT THREAD. WHEN LOOKING AT THE COUPLING SCREW THERE WERE NO THREADS. THERE WAS NO SURGICAL DELAY AS ANOTHER SET WAS OPENED. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897595 ↗
• MalfunctionOct 30, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DHS LAG SCREW CONNECTING SCREW THREAD TIP WAS BENT AND WOULD NOT THREAD INTO A LAG SCREW CORRECTLY DURING INSPECTION OF THE ACCOUNTS DHS INSTRUMENT SET. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS: LAG (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256758 ↗
• MalfunctionSep 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, A DYNAMIC HIP AND CONDYLAR SCREW (DHS/DCS) COUPLING SCREW WOULD NOT THREAD ONTO THE LAG SCREW. IT WAS DISCOVERED TO HAVE BROKEN THREADS. A NEW CONNECTING SCREW WAS SELECTED FROM THE SET AND WAS USED BUT IT WOULD NOT THREAD ONTO THE DYNAMIC HIP AND CONDYLAR SCREW (DHS/DCS) LAG SCREW. IT WAS DISCOVERED THAT THE DHS/DCS LAG SCREW HAD AN INTERNAL BLEMISH PREVENTING THE THREADING. A SECOND DHS IMPLANT SET WAS OPENED FOR A NEW DHS/DCS LAG SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNK - INSERTION INSTRUMENTS: CONNECTING / COUPLING SCREW: TRAUMA (PART # / LOT # / QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100891 ↗
• MalfunctionJun 26, 2019Device Difficult to Maintain; Patient Device Interaction Problem; Device Difficult to Maintain; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF FEMUR. DURING THE PROCEDURE, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) PLATE WOULD NOT FIT OVER A ONE (1) (DHS/DCS) GUIDE SHAFT. FOR THIS REASON, THE DOCTOR MANIPULATED ONE (1) CONNECTING SCREW WHICH CAUSED BENDING IN THE CONNECTING SCREW AND HAVING TO RESORT USING ANOTHER (DHS/DCS) TRAY AND IMPLANT TO DISCOVER THE ISSUE. THE DOCTOR WAS UNABLE TO FIX THE IMPLANT TO THE BONE. THE DOCTOR ASKED FOR AN ADDITIONAL INTRAOPERATIVE X-RAY TO DETERMINE IF THERE WAS SOMETHING WRONG WITH THE AREA THE DOCTOR REAMED IN THE FEMORAL HEAD. THE DOCTOR WANTED TO DETERMINE WHY THE ISSUE WAS OCCURRING. THE PROCEDURE OUTCOME WAS UNKNOWN WITH A THIRTY (30) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN (DHS/DCS) PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) DHS®/DCS® COUPLING SCREW. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8734987 ↗
• MalfunctionOct 8, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CONNECTING SCREW AND CHISEL BLADE WERE TAGGED AS BROKEN AT MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DHS®/DCS COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7945027 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF THE DYNAMIC HIP SCREW (DHS) SYSTEM TRAYS ON (B)(6) 2018, A CRACK WAS DISCOVERED IN THE THREADS OF THE DHS/DYNAMIC CONDYLAR SCREW (DCS) COUPLING SCREW. THERE WAS NO PROCEDURE OR PATIENT INVOLVED IN THIS COMPLAINT. THIS REPORT IS FOR A DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7857078 ↗