DHS 338.21Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982193247), received between Dec 18, 2017 and Nov 21, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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® GUIDE SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833960 ↗
• MalfunctionJan 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENT BROKE INSIDE THE LAG SCREW INSERTION. THERE WAS A SURGICAL DELAY FOR ABOUT (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 (1) DHS/DCS GUIDE SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289152 ↗
• 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) DDHS®/DCS® GUIDE SHAFT. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048724 ↗
• MalfunctionFeb 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION FOR A PATIENT WITH A RIGHT HIP FRACTURE, THE DYNAMIC HIP, AND CONDYLAR SCREW SYSTEM ( DHS/ DCS) COUPLING SCREW AND THE DHS/ DCS GUIDE SHAFT BECAME BENT AND UNUSABLE UPON INSERTION OF THE UNKNOWN DHS PLATE OVER THE UNKNOWN LAG SCREW. THE SURGEON TRIED A NEW COUPLING SCREW WHICH SUBSEQUENTLY BECAME BENT AS WELL. THE DHS/ DCS IMPACTOR WAS ALSO DAMAGED DURING THIS PROCESS. A PORTION OF THE GRAY TIP CHIPPED OFF DURING IMPACTION. THE SURGEON HAD TO USE BACKUP INSTRUMENTATION FROM A SECOND INSTRUMENT TRAY TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TEN TO FIFTEEN ( 10- 15 ) MINUTES. THE GENERATED FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN DHS PLATE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN LAG SCREW ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727942 ↗
• MalfunctionOct 31, 2018Break; Material Deformation; Break; Material Deformation

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE, HANDLE WITH QUICK COUPLING, TWO (2) HEXAGONAL SCREWDRIVER, AND DYNAMIC HIP SYSTEM/DYNAMIC CONDYLAR SYSTEM GUIDE SHAFT WERE TAGGED AS BROKEN IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WERE NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8025185 ↗
• 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 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7360196 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY FOR IMPLANTATION OF A DYNAMIC HIP SYSTEM (DHS) INTO THE PROXIMAL FEMUR ON (B)(6) 2018, IN STERILE PROCESSING, THE CONNECTING SCREW BROKE INTO TWO (2) PIECES AND THE GUIDE SHAFT, STILL IN ONE PIECE, WAS BENT TRYING TO GET THEM APART. DURING THE SURGERY, AS THE SURGEON WAS REMOVING THE CONNECTING SCREW AND GUIDE SHAFT FROM THE LAG SCREW, THE TWO INSTRUMENTS BECAME BENT (IT WAS REPORTED THAT THE SURGEON DID NOT DISCONNECT THE INSTRUMENTS PRIOR TO TAKING THEM OUT) AND THE SURGEON HAD TO USE PLIERS TO TAKE THE INSTRUMENTS OUT. THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE INTRAOPERATIVE EVENTS. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7351604 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT AN INITIAL SURGERY FOR IMPLANTATION OF A DYNAMIC HIP SYSTEM (DHS) INTO THE PROXIMAL FEMUR WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE LAG SCREW FOR THE DHS PLATE WAS PUT IN CORRECTLY, HOWEVER, THE PLATE WAS PUT IN OFF-AXIS. THEREFORE, THE PLATE HAD TO BE RE-POSITIONED, AND AS THE SURGEON WAS REMOVING THE CONNECTING SCREW AND GUIDE SHAFT FROM THE LAG SCREW, THE TWO INSTRUMENTS BECAME BENT (IT WAS REPORTED THAT THE SURGEON DID NOT DISCONNECT THE INSTRUMENTS PRIOR TO TAKING THEM OUT) AND THE SURGEON HAD TO USE PLIERS TO TAKE THE INSTRUMENTS OUT. THE SAME PLATE WAS PUT BACK INTO THE PATIENT WITHOUT ISSUE. A GUIDE WIRE WAS ALSO REPORTED TO BE BENT DURING THE SURGERY. THE PATIENT WAS IMPLANTED WITH A LAG SCREW, PLATE AND THREE 4.5 MM CORTICAL SCREWS (SIZE 36, 42 AND 48 MM). THERE WAS NO REPORTED DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT IN STERILE PROCESSING THE CONNECTING SCREW BROKE INTO TWO (2) PIECES AND THE GUIDE SHAFT, STILL IN ONE PIECE, WAS BENT TRYING TO GET THEM APART. THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE POST-OPERATIVE EVENT OF BROKEN/BENT (CONNECTING SCREW AND GUIDE SHAFT) INSTRUMENTS. CONCOMITANT DEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351416 ↗
• MalfunctionDec 18, 2017Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A LAG SCREW INSERTER WAS DAMAGED. THE ISSUE WAS FOUND PRE-OPERATIVELY. THE DEVICE WAS RECEIVED DAMAGED WHEREIN THE SLEEVES WERE TWISTED. IT IS UNKNOWN HOW THE SLEEVE GOT TWISTED AS IT WAS RECEIVED THAT WAY. THERE WAS SURGICAL TIME DELAY OF THIRTY (30) MINUTES IN LENGTH DUE TO THE DEVICE BEING DAMAGED WHEN IT WAS RECEIVED. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7125307 ↗