DHS 338.31Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10886982193322), received between Apr 28, 2017 and Apr 30, 2026 — classified as 3 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COUPLING SCREW BROKE OFF INSIDE THE BACK OF THE LAG SCREW WHILE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046863 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DHS COUPLING SCREW THREADED TIP BROKE OFF INTO THE THREADED PORTION OF THE LAG SCREW.

  Patient problems: Insufficient Information

  MAUDE report 24944409 ↗
• MalfunctionJan 13, 2026Break; Material Twisted/Bent

  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 24059197 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT COUPLING SCREW AND INSERTION WRENCH BECAME TORQUED AND WERE DISPOSED OF POST OPERATIVELY IN CSPD. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697120 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER IS BROKEN AND THE THREADS OF THE PIECE ARE BROKEN. THERE WAS NO DELAY IN SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243604 ↗
• MalfunctionOct 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIP OF THE COUPLING SCREW IS BROKEN INTO THE BACK OF THE DHS LAG SCREW. THERE WAS NO PATIENT CONSEQUENCE. DURING MANUFACTURER PRELIMINARY INVESTIGATION ON SEPTEMBER 30, 2024, IT WAS DISCOVERED THAT RETURNED CONCOMITANT DHS/DCS COUPLING SCREW WAS ALSO BROKEN IN 2 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389824 ↗
• 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 COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241627 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT ON 23-OCTOBER-2023, THE ITEM WAS BROKEN UPON RECEIPT AT THE HOSPITAL. THERE WAS NO PATIENT IMPACT. THE ISSUE WAS DISCOVERED PREOPERATIVELY. THIS REPORT INVOLVES ONE DHS®/DCS® COUPLING SCREW . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522367 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE A DHS ONE-STEP LAG SCREW WITH THE DHS/DCS ONE STEP INSERTION WRENCH AND DHS/DCS COUPLING SCREW (FOR ONE-STEP INSERTION WRENCH). AFTER APPLYING INCREASED FORCE IN ATTEMPTING TO ROTATE THE WRENCH COUNTERCLOCKWISE, THE SURGEON SUDDENLY FELT NO RESISTANCE AND THE WRENCH, WHEN TURNED COUNTERCLOCKWISE, RESULTED IN NO PROGRESS OF THE LAG SCREW BEING REMOVED. UPON INSPECTING THE COUPLING SCREW, WHICH WAS PROPERLY THREADED INTO THE LAG SCREW INITIALLY, IT WAS DETERMINED THAT THE THREADED PORTION OF THE COUPLING SCREW HAD BROKEN OFF AND REMAINED THREADED IN THE LAG SCREW. IN ADDITION, IT WAS DETERMINED THAT THE UPPER PORTION OF THE INSERTION WRENCH (THE "T") HAD LOST ITS CONNECTION TO THE SHAFT. IF THIS IS A WELD BETWEEN THE "T" PORTION OF THE WRENCH AND THE SHAFT, IT WAS THAT WELD THAT HAD BECOME DISCONNECTED. THIS RESULTED IN THE UPPER "T" PORTION ROTATING WHEN TURNED WITHOUT THE SHAFT OF THE WRENCH TURNING. ALL HARDWARE WAS EVENTUALLY REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES OUTCOME. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW THIS IS REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092644 ↗
• MalfunctionFeb 1, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT THE THREADS FROM THE TIP OF THE COUPLING SCREW WERE CUT OFF FROM THE SHAFT OF THE INSTRUMENT DURING IMPACTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621573 ↗
• MalfunctionFeb 1, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024 THAT THE TIP OF THE COUPLING SCREW IS BROKEN INTO THE BACK OF THE DHS LAG SCREW. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621485 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT ON DEC 15, 2023 THERE WAS A BROKEN COUPLING SCREW FOR DHS ONE STEP. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18510237 ↗
• MalfunctionApr 20, 2023Contamination /Decontamination Problem; No Apparent Adverse Event; Contamination /Decontamination Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WOOD HANDLED INSTRUMENTS ARE LEAVING A STAIN/RESIDUE WHEN THEY ARE PEEL-PACKED AND STERILIZED. THERE WERE NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 14 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781405 ↗
• MalfunctionApr 17, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE DHS INSTRUMENT SET WAS RECEIVED IN THE DECONTAMINATION ROOM FOR CLEANING PRIOR TO STERILIZATION AND PASSED TO THE INSTRUMENT ROOM FOR ASSEMBLY. THE INSTRUMENT ROOM TECHNICIAN NOTED THAT THE TIP OF COUPLING SCREW WAS MISSING. THE OR WAS CONTACTED AND THE SCRUB NURSE, WHO UNFORTUNATELY, THREW OUT THE TIP . NO SURGICAL DELAYED DUE TO THIS REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED AND FRAGMENTS GENERATED AND WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755487 ↗
• MalfunctionApr 17, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW IN QUESTION WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING, THE SCREW IS UNABLE TO BE USED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16754807 ↗
• MalfunctionApr 17, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW IN QUESTION WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING, THE SCREW IS UNABLE TO BE USED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753891 ↗
• MalfunctionApr 13, 2023Contamination /Decontamination Problem; No Apparent Adverse Event; Contamination /Decontamination Problem; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. UPON FURTHER INVESTIGATION IT WAS IDENTIFIED THAT THE PRODUCT 338.31 REPORTED UNDER 8030965-2023-04630 WAS INCORRECT PRODUCT. THE CORRECT PRODUCT IS SPINE PRODUCT 388.31. SINCE 388.31 IS A SPINE PRODUCT, THIS COMPLAINT IS REPORTED UNDER SPINE OPERATING COMPANY UNDER 8030965-2023-05975.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738317 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT ON DECEMBER 24, 2022, THE TIP TO DHS COUPLING SCREW WAS DISCOVERED AS BROKEN DURING THE PROCEDURE. PROCEDURE WAS STILL COMPLETED WITHOUT INTERRUPTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT OUTCOMES/CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214384 ↗
• MalfunctionSep 5, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSTRUMENT ROOM TECHNICIAN WAS ASSEMBLING THE INSTRUMENT SET AND NOTICED THAT THE TIP OF THE COUPLING SCREW WAS BROKEN OFF. ADDITIONALLY, TWO REDUCTION FORCEPS WERE FOUND WITH THEIR INSPECTING TIPS OUT OF ALIGNMENT AND BENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS®/DCS® COUPLING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355267 ↗
• MalfunctionJul 27, 2022Break; Break

  IT WAS REPORTED ON UNKNOWN DATE THAT DHS/DCS COUPLING SCREW WAS RECEIVED AS BLIND UNIT. PRODUCT CODE:338.310 , LOT# 237P610. HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111580 ↗
• MalfunctionJun 16, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715726 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE TWO (2) DYNAMIC HIP SYSTEM COUPLING SCREWS WERE NOTICED BROKEN AFTER A WASH CYCLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054529 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE TWO (2) DYNAMIC HIP SYSTEM COUPLING SCREWS WERE NOTICED BROKEN AFTER A WASH CYCLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DHS/DCS COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054505 ↗
• MalfunctionMar 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A DHS REVISION FOR TOTAL HIP ARTHROPLASTY, TWO DHS/DCS COUPLING SCREWS BROKE AT THE THREADS. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742612 ↗
• MalfunctionMar 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, DURING A DHS REVISION FOR TOTAL HIP ARTHROPLASTY, TWO DHS/DCS COUPLING SCREWS BROKE AT THE THREADS. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) DHS®/DCS® COUPLING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742544 ↗