DHS 338.28Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982193308), received between Jun 13, 2018 and Apr 2, 2025 — classified as 1 injury, 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE PROCEDURE, WHICH WAS A STANDARD DHS, UPON FOLLOWING THE STEPS PER THE SURGICAL TECHNIQUE, THE DHS/DCS IMPACTOR BROKE WHILE TRYING TO SEAT THE PLATE. SPECIFICALLY, THE TIP OF THE IMPACTOR BROKE. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE IMPACTOR. THE BROKEN TIP WAS RECOVERED, HOWEVER THE IMPACTOR AND TIP AS A WHOLE WERE UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 21756454 ↗
• MalfunctionMar 22, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION IN OF THE DHS SET, IT WAS DISCOVERED THAT THE DHS/DCS IMPACTOR WAS BROKEN. IT WAS DISCARDED. THERE WAS NO PATIENT CONSEQUENCE; THE ISSUE WAS DISCOVERED POSTOPERATIVELY. THIS REPORT INVOLVES ONE DHS®/DCS® IMPACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959379 ↗
• MalfunctionOct 20, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH DHS/DCS IMPACTOR. DURING SURGERY, THE DHS/DCS IMPACTOR IN QUESTION WAS USED TO INSERT THE TUBE PLATE BARREL PART INTO THE BODY, AND WHEN IT WAS STRUCK WITH A HAMMER, THE TIP OF THE DHS/DCS IMPACTOR BROKE AFTER BEING STRUCK SEVERAL TIMES. THE SURGERY WAS CONTINUED USING AN IN-HOSPITAL SUBSTITUTE AND WAS COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS®/DCS® IMPACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17974465 ↗
• MalfunctionFeb 22, 2022Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DHS IMPACTOR WAS UNABLE TO STERILIZE AND ASSEMBLE. CHIPPING AND CRACKING WERE NOTED. THIS MAY HAVE HAPPENED DURING CLEANING IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE DHS/DCS IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580231 ↗
• InjuryJan 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A HIP SURGERY, A PIECE OF A BROKEN DYNAMIC HIP SYSTEM (DHS) SCREW WAS FOUND. THE SURGEON DID THE CASE TO WASH OUT A HIP THAT HAD A HEMATOMA. INITIALLY, THE PATIENT HAD A FACILITY DYNAMIC HIP SCREW PUT IN ON AN UNKNOWN DATE. WHEN THE SURGEON WASHED THE HIP OUT, A PIECE OF SOMETHING CAME OUT. IT APPEARS A SMALL PIECE OF THE IMPACTOR FOR THE DYNAMIC HIP SYSTEM (DHS) HAD BROKEN OFF WHEN THE INITIAL SURGERY OCCURRED. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DHS®/DCS® IMPACTOR. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Hematoma

  MAUDE report 11132729 ↗
• MalfunctionDec 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) IMPACTOR BROKE OFF DURING USE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) DHS®/DCS® IMPACTOR. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098279 ↗
• MalfunctionDec 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) IMPACTOR BROKE OFF DURING USE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) DHS®/DCS® IMPACTOR. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098239 ↗
• MalfunctionFeb 19, 2020Break; Break

  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® IMPACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727936 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY, THE PLASTIC TIP OF THE DYNAMIC HIP AND CONDYLAR SYSTEM (DHS/DCS) IMPACTOR BROKE DURING REGULAR USE TO IMPACT DYNAMIC HIP SCREW PLATE TO BONE. THE SURGEON PROCEEDED TO USED A BONE TAMP TO IMPACT THE PLATE TO BONE AFTER THE DYNAMIC HIP SCREW (DHS) IMPACTOR BROKE. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES: PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS/DCS IMPACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370440 ↗
• MalfunctionOct 31, 2018Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE DYNAMIC HIP SCREW (DHS) PLATE IMPACTOR BROKE. THE PROCEDURE WAS COMPLETED USING A SIMILAR INSTRUMENT. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A DHS®/DCS® IMPACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025042 ↗
• MalfunctionJun 13, 2018Break; Break

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, WHILE USING THE MALLET AND IMPACTOR TO PUSH THE DHS PLATE TO THE BONE, A PIECE OF THE GRAY PLASTIC IMPACTOR BROKE OFF. THE PIECE WAS RETRIEVED EASILY WITHOUT ADDITIONAL INTERVENTION, AND THE IMPACTOR WAS STILL USABLE ENOUGH TO FINISH THE CASE. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICE(S) REPORTED: IMPACTION INST: HAMMER/MALLET: TR (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1) DHS/DCS PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597354 ↗