SUMMIT 2570-00-000Recalls & reported problems
Depuy (Ireland) · SUMMIT BROACH HANDLE · Class 1
All models of SUMMIT (43)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Summit broach handle appears in 268 adverse event reports, with no deaths and no injuries. The reports mostly describe handles that do not fit or lock with other instruments, parts that break off, and loose clamps that do not hold the broach securely, with many reports noting no patient impact. Reports fell to 4 in the last 12 months from 17 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 269
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 10603295142843), received between Jul 7, 2017 and Sep 10, 2026 — classified as 269 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (137 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
- Device-Device Incompatibility137
- Unintended Movement77
- Break42
- Loose or Intermittent Connection21
- Appropriate Device Problem Term/Code Not Available11
- Naturally Worn11
- Structural Problem10
- Scratched Material9
Patient problems
- No Consequences Or Impact To Patient119
- No Clinical Signs, Symptoms or Conditions118
- Insufficient Information21
- No Information10
- No Code Available2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Device-Device Incompatibility
It was reported that broach handle would not lock.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717877 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227829 ↗MalfunctionJul 9, 2026Device-Device Incompatibility; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765288 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STRIKE PLATE WAS BROKEN OFF BROACH HANDLE, THE REAMER HANDLE WOULD NOT FIT IN THE CHUCK, AND IT WAS VERY HARD TO DISASSEMBLE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889544 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT THE SUMMIT UNIVERSAL BROACH HANDLE HAD A BROKEN LOCKING MECHANISM ON A CONSIGNMENT C STEM BROACH HANDLE. THE EVENT OCCURRED PRE-OPERATIVELY, AND A REPLACEMENT WAS REQUESTED. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829878 ↗MalfunctionOct 24, 2025Break; Break
IT WAS REPORTED THAT THE WHITE HANDLED CUP INSERTER WAS CHIPPED ON THE HANDLE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380330 ↗MalfunctionAug 8, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE CLAMP IS TOO LOOSE TO SECURELY HOLD THE BROACH. THE SURGERY WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22754227 ↗MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT (RIGHT). THE LEVER BROKE. DEVICE IS STILL ATTACHED BUT DOESN¿T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726666 ↗MalfunctionAug 4, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BROACH HANDLE WAS NOT LOCKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22703521 ↗MalfunctionJun 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE DOESN'T STAY LOCKED AND NEEDS REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22308249 ↗MalfunctionJun 10, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLES ARE LOOSE. PINNACLE LINER IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177690 ↗MalfunctionJun 10, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLES ARE LOOSE. PINNACLE LINER IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177588 ↗MalfunctionMar 25, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOTH BROACH HANDLES WERE NOT HOLDING THE BROACHES AS THEY SHOULD BE. IT WAS AN EXTREMELY LOOSE FIT.
Patient problems: Insufficient Information
MAUDE report 21686214 ↗MalfunctionMar 25, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BOTH BROACH HANDLES WERE NOT HOLDING THE BROACHES AS THEY SHOULD BE. IT WAS AN EXTREMELY LOOSE FIT.
Patient problems: Insufficient Information
MAUDE report 21686208 ↗MalfunctionFeb 25, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE NOT CLOSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462567 ↗MalfunctionFeb 20, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THERE WAS A LOOSE BROACH HANDLE WHICH WAS WORN OUT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21425679 ↗MalfunctionJan 22, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH HANDLE WOULD NOT LOCK. STAFF HAD TO OPEN ANOTHER TRAY. THERE WAS NO DELAY AND THE INCIDENT WAS CAUGHT BEFORE STAFF STARTED TO BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208577 ↗MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCRUB TECH WAS TRYING TO ATTACH A BROACH TO THE BROACH HANDLE AND THE LATCH WAS NOT HOLDING THE BROACH IN PLACE AND IT KEPT FALLING OUT. ALL PIECES WERE RECOVERED FROM THE FIELD AND THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21102411 ↗MalfunctionDec 10, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT HANDLE IS LAX WHEN ATTACHING BROACH.
Patient problems: Insufficient Information
MAUDE report 20895288 ↗MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH HANDLE WOULD NOT LATCH SHUT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20728534 ↗MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO SURGICAL DELAY. NO AFFECTS ON THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20724582 ↗MalfunctionNov 7, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE BROACH HANDLE WAS LOOSE.
Patient problems: Insufficient Information
MAUDE report 20633323 ↗MalfunctionOct 28, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE HANDLE WAS VERY LOOSE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545276 ↗MalfunctionOct 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SUMMIT BROACH HANDLE CAME UNLATCHED. THERE WAS NO IMPACT TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480844 ↗MalfunctionOct 7, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE LOCK MECHANISM IS LOOSE AND DID NOT RETAIN THE BROACH WELL. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20389468 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 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
- CORAIL 952210500FDepuy (Ireland) · BROACH157 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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