DHS 338.26Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982193292), received between Apr 13, 2017 and Aug 12, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE THE TIP OF THE DHS IMPACTOR IS DAMAGED AND NEEDS REPLACED. THE TIP IS CHIPPING AND PARTS BROKEN OFF. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. IT WAS FINISHED IMPACTING TO GET IMPLANT DOWN. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22788452 ↗
• 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 21756606 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE WHILE WORKING ON SETS, IT WAS DISCOVERED THAT THE IMPACTOR TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TIP FOR DHS/DCS IMPACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520146 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A DHS CASE OVER THE PAST HOLIDAY WEEKEND, AFTER THE LAG SCREW A CORRECTLY IMPLANTED, THE PLATE WAS THEN INSERTED OVER THE LAG SCREW. THE PLATE WAS THEN MALLETED OVER THE TOP TO SIT FLUSH WITH THE LATERAL CORTEX, UPON MALLETING WITH THE MALLET AND IMPACTOR, THE PLASTIC END OF THE IMPACTOR BROKE INTO TWO PIECES. ONCE THE PIECE (338.26) BROKE, THE SURGEON AND RESIDENT AGREED THAT THE IMPLANT WAS PERFECTLY PLACED AND NO FURTHER MALLETING WAS NECESSARY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) TIP FOR DHS/DCS IMPACTOR (338.28) THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519488 ↗
• MalfunctionDec 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2023 THE TIP OF AN IMPACTOR BROKE OFF INTRAOPERATIVELY DURING IMPACTION. NO SURGICAL DELAY REPORTED. PROCEDURE COMPLETELY SUCCESSFULLY. THIS REPORT IS FOR TIP FOR DHS/DCS IMPACTOR (338.28) FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275625 ↗
• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A HIP SURGERY ON (B)(6) 2023, THE DHS IMPACTOR PIECE BROKE OFF WHILE IN USE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277672 ↗
• MalfunctionMar 16, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES, REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE IMPACTOR TIP WAS SPLIT OPEN DURING INSERTION. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TIP FOR DHS/DCS IMPACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16558394 ↗
• MalfunctionJul 11, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THE TIP OF IMPACTOR WAS WORN-OUT. NO KNOWN PATIENT OR SURGICAL INVOLVEMENT. DURING INVESTIGATION IT WAS DETERMINED THAT THE DEVICE TIP BROKE. IT IS UNKNOWN WHEN MALFUNCTION OCCURRED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A DHS/DCS IMPACTOR TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977136 ↗
• MalfunctionMay 23, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DHS IMPACTOR TIP CHIPPED OFF. THIS COMPLAIN INVOLVES ONE DEVICE INS F/DHS/DCS IMPACTOR NO. 338.280 SINGL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468867 ↗
• MalfunctionApr 21, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A DYNAMIC HIP SCREW (DHS) SYSTEM IMPACTOR WAS NOTED AS DAMAGED IN A DHS SET. THE DEVICE HAS BEEN DAMAGED THROUGHOUT YEARS OF USE. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A DHS IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166977 ↗
• MalfunctionApr 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT PLASTIC PORTION OF DHS IMPACTOR BROKE OFF DURING INSERTION. PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES ONE(1) DEVICE DHS/DCS IMPACTOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053623 ↗
• MalfunctionJan 20, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, THE TIP FOR DHS IMPACTOR WAS BROKEN. A FRAGMENT WAS GENERATED AND WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308337 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE INSERTING A DYNAMIC HIP SYSTEM (DHS) PLATE WITH THE IMPACTOR, THE PLASTIC PORTION OF THE IMPACTOR BROKE. THE PIECES WERE RETRIEVED SUCCESSFULLY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM OR SURGERY DELAY. THIS REPORT INVOLVES ONE (1) TI TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258588 ↗
• 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 (338.28) (PART NUMBER 338.26, LOT 6043333, QUANTITY 1), DHS®/DCS® COUPLING SCREW (PART NUMBER 338.20, LOT 1165694, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560202 ↗
• 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 (338.28) (PART NUMBER 338.26, LOT H479753, QUANTITY 1), DHS®/DCS® COUPLING SCREW (PART NUMBER 338.20, LOT 1165694, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560155 ↗
• MalfunctionSep 15, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, A DYNAMIC HIP SCREW (DHS) IMPACTOR BROKE DURING IMPACTION OF THE DHS PLATE. ANOTHER SET WAS OPENED TO COMPLETE THE CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO (2) MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. AN ADDITIONAL DEVICE WAS RECEIVED BY THE MANUFACTURER ON AUGUST 24, 2020. CONCOMITANT DEVICES: DHS/DCS PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TIP FOR DHS®/DCS® IMPACTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535195 ↗
• MalfunctionAug 27, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, A PIECE BROKE OFF THE END OF THE IMPACTOR FOR DYNAMIC HIP SCREW/DYNAMIC CONDYLAR SCREW (DHS/DCS). THIS WAS NOTICED DURING CLEANING. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR A TIP FOR DHS®/DCS® IMPACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10459330 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING IMPACTION OF THE UNKNOWN DHS PLATE. THE IMPACTOR TIP BROKE OFF. ALL PIECES WERE REMOVED. FRAGMENTS WERE GENERATED, THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGERY DELAY. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATES: DHS/DCS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239635 ↗
• MalfunctionJun 4, 2020Break; Break

  CONCOMITANT DEVICES REPORTED: UNK - PLATES: DHS/DCS (PART#UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118596 ↗
• MalfunctionMar 25, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE DHS IMPACTOR WAS BROKEN DURING IMPACTION OF THE DHS PLATE. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: DHS/DCS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879851 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP FOR DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) IMPACTOR BROKE. THE ISSUE WAS FOUND OUT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401873 ↗
• MalfunctionAug 29, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF THE TWO (2) DYNAMIC HIP SYSTEM (DHS) IMPACTORS BROKE. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) TIP FOR DHS/DCS IMPACTOR (338.28). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946118 ↗
• MalfunctionAug 29, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF THE TWO (2) DYNAMIC HIP SYSTEM (DHS) IMPACTORS BROKE. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) TIP FOR DHS/DCS IMPACTOR (338.28). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946094 ↗
• MalfunctionMay 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, THERE WERE NOTCHES ON THE PLASTIC HANDLE OF THE INSERT FOR DYNAMIC HIP SCREW (DHS)/DYNAMIC CONDYLAR SCREW (DCS) IMPACTOR. THE DHS/DCS IMPACTOR ALSO WOULD DISCONNECT. IT IS UNKNOWN IF WHEN WAS THE ISSUE WAS DISCOVERED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TIP FOR DHS®/DCS® IMPACTOR (338.28). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599944 ↗
• MalfunctionJun 19, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A DYNAMIC HIP SCREW/ DYNAMIC CONDYLAR SCREW (DHS/DCS) IMPACTOR WAS FOUND BROKEN AND UNUSABLE DURING RESTOCKING OF SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TIP FOR DHS®/DCS® IMPACTOR (338.28) THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7613809 ↗