SUMMIT 2570-00-135Recalls & reported problems
Depuy (Ireland) · SUMMIT BROACH SIZE 7 · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295142942), received between Nov 8, 2017 and Mar 13, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Break” (13 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.
Reports received per month
Most reported problems
Device problems
- Break13
- Device-Device Incompatibility4
- Illegible Information4
- Material Twisted/Bent4
- Dull, Blunt2
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient5
- Not Applicable4
- Insufficient Information1
- No Code Available1
- No Information1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE SUMMIT BROACH BROKE INTO 2 PIECES DURING THE REMOVAL PROCESS. THERE WAS 5 MINUTES SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597258 ↗MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT THE SUMMIT 7 BROACH POST BROKE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20833110 ↗MalfunctionNov 8, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL HIP WITH TEMPORARY PARTS DUE TO AN INFECTION. THE INFECTION IS GONE, SO THE SURGEON REMOVED THE TEMPORARY COMPONENTS AND IMPLANTED DEFINITIVE PARTS. DURING BROACHING OF THE FEMUR, THE MALE END OF THE BROACH BROKE OFF. ALL PIECES WERE FOUND. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644618 ↗MalfunctionJun 20, 2024Break; Break
IT WAS REPORTED THAT TOP PORTION, "FLANGE" OF DEPUY SUMMIT FEMORAL BROACH BROKE OFF WHILE BROACHING IN PATIENTS LEFT FEMORAL CANAL. THE BROACH WAS THEN LODGED IN THE FEMORAL CANAL, AND THE BROACH HANDLE/EXTRACTOR COULD NO LONGER BE ATTACHED TO THE BROACH TO EXTRACT IT FROM THE PATIENT'S FEMORAL CANAL. EVENTUALLY THE SURGEON AND OR TEAM WERE ABLE TO REMOVE THE BROKEN BROACH AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578874 ↗MalfunctionJul 21, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ADAPTOR ON THE SIZE 7 SUMMIT BROACH IS BENT AND WOULD NOT ACCEPT A BROACH HANDLE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17372392 ↗MalfunctionJun 22, 2023Break; Break
IT WAS REPORTED THAT THE #7 SUMMIT BROACH WAS REMOVED FROM THE FEMORAL CANAL WITH THE D257000002 EXTRACTOR AFTER THE TRUNION ON THE BROACH SNAPPED OFF. SURGERY WAS DELAYED 20 MINUTES. THE FRAGMENTS WERE EASILY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183036 ↗MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SUMMIT BROACH SIZE 7 GETS STUCK IN KINCISE BROACH HANDLE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16878637 ↗MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility
THE TAPERED BROACH WILL NOT SEAT PROPERLY INSIDE THE BROACH HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14238161 ↗MalfunctionFeb 11, 2022Break; Break
IT WAS REPORTED THAT THE METAL FLAKES WERE COMING OFF BROACH WHEN CALCAR REAMING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13515153 ↗MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11541740 ↗MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN'T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11541697 ↗MalfunctionAug 18, 2020Break; Break
IT WAS REPORTED THAT THE ATTACHMENT PEG OF THE SUMMIT BROACH BROKE OFF DURING TRIALING. THE BROACH NEEDS TO BE REPLACED. SURGICAL DELAY 5 MINUTES.
Patient problems: No Code Available
MAUDE report 10420935 ↗MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; Material Twisted/Bent; Illegible Information
SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9867984 ↗MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; Material Twisted/Bent; Illegible Information
SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9867974 ↗MalfunctionSep 17, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEFT TOTAL HIP WHEN THE MALE END OF THE BROACH BROKE OFF DURING BROACHING. WE WERE USING THE DOUBLE OFFSET BROACH HANDLES. IT WAS DIFFICULT TO RETRIEVE THE BROACH OUT OF THE FEMUR WITHOUT ANYTHING TO GRAB IT WITH. ALL PIECES WERE FOUND. THE HOSPITAL THREW THE BROACH AWAY, SO I AM UNABLE TO RETURN. SURGICAL DELAY OF 5 MINUTES.
Patient problems: Not Applicable
MAUDE report 9075747 ↗MalfunctionAug 30, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT WAS HAVING A RIGHT TOTAL HIP. DURING THE BROACHING OF THE FEMUR, THE MALE END ON THE SUMMIT BROACH BROKE OFF. THE SURGEON WAS USING THE DOUBLE OFFSET BROACH HANDLES. THE PIECE WAS FOUND. IT TOOK 5 MINUTES TO GET THE BROACH OUT OF THE FEMUR. THE HUDSON ADAPTER ALSO BROKE DURING REAMING OF THE FEMORAL CANAL. ALL PIECES ARE PRESENT.
Patient problems: Not Applicable
MAUDE report 8951315 ↗MalfunctionApr 4, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE BROACH CONNECTION POINT IS MALFUNCTIONING, UNABLE TO SECURELY CONNECT TO A BROACH HANDLE. OCCURRED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8482873 ↗MalfunctionApr 4, 2019Break; Break
IT WAS REPORTED THAT THIS PATIENT WAS HAVING A LEFT TOTAL HIP. DURING BROACHING OF THE FEMORAL CANAL, THE MALE END OF THE SUMMIT #7 BROACH BROKE OFF. THE SURGEON WAS USING THE DOUBLE OFFSET BROACH HANDLES. THE PIECE WAS FOUND. IT TOOK 5 MINUTES TO EXTRACT THE BROACH FROM THE FEMUR WITHOUT A TIP TO GRAB ONTO.
Patient problems: Not Applicable
MAUDE report 8482870 ↗MalfunctionNov 15, 2018Break; Break
MalfunctionSep 14, 2018Break; Break
SUMMIT BROACH BROKE. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7876896 ↗MalfunctionDec 15, 2017Break; Break
IT WAS REPORTED THAT THE TIP OF BROACH BROKE OFF WHEN SURGEON WAS PUTTING BROACH HANDLE ON TO REMOVED FROM FEMUR. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7120740 ↗MalfunctionNov 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT BEFORE THE SURGERY THE HOSPITAL STAFF NOTICED THE FOLLOWING ISSUES. BROACH HANDLE COULD NOT BE CONNECTED TO THE BROACH SIZE: 7. HOWEVER, THIS BROACH HANDLE COULD BE CONNECTED TO ANY BROACH SIZE OTHER THAN THE BROACH SIZE: 7.
Patient problems: No Information
MAUDE report 7009060 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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