DHS 338.23Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982193278), received between Dec 21, 2016 and Oct 25, 2024 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE INSTRUMENT BENT DURING SURGERY OR CLEANING. IT'S UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20533817 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 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® GUIDE SHAFT WITH FLATS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19382454 ↗
• MalfunctionMay 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE TINES OF THE GUIDE SHAFT WERE BENT/BROKEN. THIS REPORT IS FOR A DHS/DCS GUIDE SHAFT WITH FLATS.

  Patient problems: Insufficient Information

  MAUDE report 19323320 ↗
• MalfunctionMay 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE TINES OF THE GUIDE SHAFT WERE BENT/BROKEN. THIS REPORT IS FOR A DHS/DCS GUIDE SHAFT WITH FLATS.

  Patient problems: Insufficient Information

  MAUDE report 19323303 ↗
• MalfunctionNov 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN SETTING UP FOR A DHS IN THE MORNING AT THE HOSPITAL, IT WAS NOTICED THAT ONE OF THE SETS THERE HAD INSTRUMENTS THAT WERE DAMAGED AND NOT FUNCTIONING PROPERLY. LUCKILY, THEY HAD A BACKUP TRAY; HOWEVER, THE LOCKING NUT FOR THE TRIPLE REAMER WOULD NOT THREAD ONTO THE STANDARD REAMER HEAD, AND THE TINES FOR THE GUIDESHAFT WITH FLATS WERE BENT. THIS REPORT IS FOR ONE (1) DHS/DCS GUIDE SHAFT WITH FLATS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18092911 ↗
• MalfunctionJul 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED ON MAY 31, 2023, THE DEVICES ARE NOT PROPERLY SEATING WITH SCREW. THERE WAS NO OPERATION INVOLVED. THERE WERE NO PATIENT OUTCOMES REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) DHS/DCS CENTERING SLEEVE LONG. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332601 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THE FLANGES ON THE DEVICES WERE BENT. THERE WAS NO PATIENT OR OPERATION INVOLVED. THIS REPORT INVOLVES ONE DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136891 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THE FLANGES ON THE DEVICES WERE BENT. THERE WAS NO PATIENT OR OPERATION INVOLVED. THIS REPORT INVOLVES ONE DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136887 ↗
• 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 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340221 ↗
• MalfunctionAug 19, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE DHC GUIDE SHAFT WAS BENT AND NO LONGER ABLE TO THREAD ONTO THE IMPLANT. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR A GUIDE SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343794 ↗
• MalfunctionAug 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT FOLLOWING DEVICES WERE RECEIVED DAMAGED AT THE BLIND UNIT: PRODUCT CODE: 314.190; LOT# L534677. PRODUCT CODE 338.23; LOT# 7416972. PRODUCT CODE 319.006; LOT# 6536070. PRODUCT CODE 338.200; LOT# 1077132. THIS REPORT IS FOR ONE (1) DHS/DCS GUIDE SHAFT WITH FLATS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318216 ↗
• MalfunctionOct 29, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN DATE DURING A DYNAMIC HIPS SCREW (DHS) SURGERY, THE COUPLE SCREW THREADING WAS NOTED TO BE DIFFICULT TO USE, AND GUIDE SHAFT BENT. SECONDARY SET WAS USED. THERE WAS NO PATIENT CONSEQUENCES, AND NO SURGICAL DELAY WAS NOTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: CONNECTOR SHORT (PART # 338.2, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759250 ↗
• MalfunctionJul 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, WHILE INSERTING AN UNKNOWN DYNAMIC HIP SCREW (DHS) LAG SCREW, A PORTION OF THE COUPLING SCREW BROKE OFF AND THE GUIDE SHAFT STRIPPED OFF THE SCREW LEAVING PART OF THE COUPLING SCREW INCARCERATED IN THE LAG SCREW RENDERING IT BROKEN. HENCE, A PIECE OF THE COUPLING SCREW WAS LEFT INSIDE THE LAG SCREW, WHICH WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND A NEW LAG SCREW IMPLANTED. THE PROCEDURE WAS FINISHED SUCCESSFULLY USING A SECOND DHS INSTRUMENT SET. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DHS/DCS GUIDE SHAFTS WITH FLATS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842589 ↗
• MalfunctionJun 26, 2019Material Twisted/Bent; Patient Device Interaction Problem; Material Twisted/Bent; 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 REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8735033 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SEVERAL DEVICES WERE DISCOVERED DAMAGED. THE 2.4MM STARDRIVE SCREWDRIVER SHAFT TIP WAS BENT. THE TWO (2) DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS) GUIDE SHAFT WITH FLAT S INSERTER TIP HAVE TWISTED AND BROKEN OFF. THE UNIVERSAL CHUCK WITH T-HANDLE WAS BENT BADLY. THE INTER-LOCK SCREWDRIVER TIP WAS BENT. THE REDUCTION FORCEPS WITH POINTS NARROW-RATCHET BOTH TIPS WERE BROKEN OFF. THE BENDING PLIERS FOR RECONSTRUCTION PLATES, THE PIECE HOLDING BENDER TOGETHER FELL OUT, SO PIECES NO LONGER STAY TOGETHER. THE TIP OF DEPTH GAUGE SCREWS BROKE OFF THE MEASURER. PATIENT INVOLVEMENT AND CONSEQUENCE ARE UNKNOWN. THIS REPORT IS FOR A DHS®/DCS® GUIDE SHAFT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267764 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SEVERAL DEVICES WERE DISCOVERED DAMAGED. THE 2.4MM STARDRIVE SCREWDRIVER SHAFT TIP WAS BENT. THE TWO (2) DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS) GUIDE SHAFT WITH FLAT S INSERTER TIP HAVE TWISTED AND BROKEN OFF. THE UNIVERSAL CHUCK WITH T-HANDLE WAS BENT BADLY. THE INTER-LOCK SCREWDRIVER TIP WAS BENT. THE REDUCTION FORCEPS WITH POINTS NARROW-RATCHET BOTH TIPS WERE BROKEN OFF. THE BENDING PLIERS FOR RECONSTRUCTION PLATES, THE PIECE HOLDING BENDER TOGETHER FELL OUT, SO PIECES NO LONGER STAY TOGETHER. THE TIP OF DEPTH GAUGE SCREWS BROKE OFF THE MEASURER. THIS REPORT IS FOR A DHS®/DCS® GUIDE SHAFT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267715 ↗
• MalfunctionJun 29, 2018Bent; Bent

  IT WAS REPORTED THAT DURING A HIP SURGERY ON (B)(6) 2018, THE SURGEON NOTICED THAT THE GUIDE SHAFT WITH FLATS WOULD NOT ABLE TO FIRMLY INSERT INTO THE WRENCH UPON COMPLETION OF THE LAG SCREW INSERTION ASSEMBLY. THE TABS ON THE GUIDE SHAFT WERE BENT PREVENTING A FULL INSERTION. A 30-MINUTE SURGICAL DELAY WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN WRENCH (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY #1), UNKNOWN LAG SCREW (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY #1) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650637 ↗
• MalfunctionJun 20, 2018Bent; Bent

  IT WAS REPORTED THAT FOUR (4) INTERLOCKING BOLTS WERE FOUND TO BE STRIPPED. THE TWO PRONGS ON EITHER SIDE OF THE GUIDE SHAFT WAS BENT. AS A RESULT, THE COUPLING SCREW BECAME STRIPPED. THIS WAS DISCOVERED WHEN THE SET WAS PUT TOGETHER DURING STERILE PROCESSING ON (B)(6) 2018. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7622521 ↗
• MalfunctionJun 20, 2018Bent; Bent

  IT WAS REPORTED THAT DURING REFILLING OF INSTRUMENT AFTER THE OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR PROXIMAL FEMUR ON (B)(6) 2018, THE SALES CONSULTANT DISCOVERED THAT THE COUPLING SCREW AND THE CENTERING SLEEVE WAS BENT. REPORTEDLY, IT IS UNKNOWN IF IT OCCURRED DURING THE PROCEDURE, DURING WASH OR ANY OTHER TIME. THERE WAS NO DELAY OR ISSUE IN THE PROCEDURE. PROCEDURE WAS COMPLETED AS PLANNED AND THE OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) DHS®/DCS® GUIDE SHAFT WITH FLATS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7619331 ↗
• MalfunctionMay 4, 2018Bent; Bent

  IT WAS REPORTED THAT TWO INSTRUMENTS HAVE SLIGHT BENDS IN THE TIPS, CAUSING THEM NOT TO COUPLE WITH THE DHS SCREW PROPERLY. THIS DISCOVERY WAS MADE DURING THE ROUTINE CHECK OF THE DEVICES. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVE 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7488645 ↗
• MalfunctionFeb 23, 2018Break; Break

  IT WAS REPORTED DURING A DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS) PROCEDURE ON (B)(6) 2018, THE TEETH BROKE OFF FROM THE DHS/DCS GUIDE SHAFT AND THE DHS/DCS COUPLING SCREW BROKE. ALL FRAGMENTS WERE RETRIEVED. IT WAS ALSO DETERMINED THE FIRST DHS/DCS LAG SCREW INSERTED WAS TOO LONG FOR THE PATIENT¿S ANATOMY. SURGEON USED A DIFFERENT DHS/DCS GUIDE SHAFT AND DHS/DCS COUPLING SCREW TO CHANGE OUT THE DHS/DCS LAG SCREW TO A SHORTER DEVICE IN ORDER TO ACCOMMODATE THE PATIENT¿S ANATOMY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 4 MINUTES. CONCOMITANT DEVICES REPORTED: DHS/DCS LAG SCREW 12.7MM THREAD/100MM (PART 280.000, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) DHS/DCS GUIDE SHAFT WITH FLATS THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292449 ↗
• MalfunctionNov 2, 2017Bent; Failure to Align; Bent; Failure to Align

  CONCOMITANT DEVICES REPORTED: LAG SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998308 ↗
• MalfunctionFeb 13, 2017Bent; Break; Bent; Break

  IT WAS REPORTED THAT ONE (1) DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS®/DCS®) GUIDE SHAFT WITH FLATS AND ONE (1) DHS®/DCS® COUPLING SCREW ARE BENT AND BROKEN IN TWO (2) PIECES. THE ISSUE WAS DISCOVERED ON (B)(6) 2017 AT STERILE PROCESSING. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6327842 ↗
• MalfunctionFeb 7, 2017Bent; Bent

  IT WAS REPORTED THAT DURING STERILE PROCESSING, TWO (2) DHS/DCS GUIDE SHAFTS WERE NOTED TO BE BENT. THE FIRST DEVICE IS SLIGHTLY BENT IN THE MIDDLE OF THE SHAFT AND THE TWO PRONGS AT THE TIP OF THE SHAFT ARE ALSO BENT. THE TWO PRONGS ON THE TIP OF THE SECOND DEVICE ARE BENT. THERE WAS NO REPORTED PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR THE FIRST DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6309218 ↗
• InjuryDec 21, 2016Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A DYNAMIC HIP SCREW (DHS) PROCEDURE FOR A RIGHT LEG HIP FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT WAS COMPLETED ON (B)(6) , 2016. WHILE INSERTING THE LAG SCREW AND DURING THE FINAL TIGHTENING OF THE LAG SCREW, THE SURGEON TURNED THE T-HANDLE WRENCH WHICH IS CONNECTED TO THE GUIDE SHAFT INSTRUMENT. THE GUIDE SHAFT INSTRUMENT TWISTED, AND BECAME DAMAGED AND BENT WHICH CAUSED THE SURGEON TO BE UNABLE TO SLIDE THE PLATE OVER THE LAG SCREW IMPLANT. SURGEON SELECTED ANOTHER GUIDE SHAFT INSTRUMENT FROM THE SET THAT WAS AVAILABLE IN THE OPERATING ROOM, BUT THIS INSTRUMENT ALSO BECAME DAMAGED AND BENT. SURGEON SELECTED ANOTHER GUIDE SHAFT INSTRUMENT AND AGAIN DURING TIGHTENING, ONE OF THE TINES AT THE END OF THE INSTRUMENT BROKE OFF. THE BROKEN TINE FRAGMENT WAS RETRIEVED FROM THE PATIENT. ADDITIONAL IMAGES WERE USED TO IDENTIFY THE FRAGMENT PLACEMENT. AT THIS POINT IN THE PROCEDURE, THE SURGEON REMOVED THE PREVIOUSLY IMPLANTED LAG SCREW, AND RE-IMPLANTED A NEW LAG SCREW AND CONTINUED ONWARD WITH THE PROCEDURE. DUE TO THIS EVENT THERE WAS A 45 MINUTE DELAY IN OPERATING ROOM TIME. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS REPORTED IN STABLE CONDITION. CONCOMIT

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6194807 ↗