NA 2598-07-550Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS EXTRA CURVED BROACH HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy extra curved broach handle is a surgical instrument used in hip replacement surgery. The 321 reports, all malfunctions, mostly describe the handle not holding broaches securely, loosening, or breaking, and most report no effect on patients. No deaths and no injuries are reported. No recalls name this device. Reports fell to 1 in the last 12 months from 21 in the previous 12.
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
- 323
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 10603295148531), received between Jun 30, 2017 and Sep 18, 2026 — classified as 323 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (168 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility168
- Unintended Movement96
- Loose or Intermittent Connection41
- Break32
- Appropriate Device Problem Term/Code Not Available23
- Naturally Worn18
- Device Slipped15
- Structural Problem13
Patient problems
- No Consequences Or Impact To Patient179
- No Clinical Signs, Symptoms or Conditions124
- No Information11
- Insufficient Information9
- No Code Available4
- No Known Impact Or Consequence To Patient3
- Not Applicable3
Recent adverse event reports
The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device-Device Incompatibility
It was reported that the broach handle wouldn¿t lock on broach, The reporter used the other broach handle for this case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821813 ↗MalfunctionSep 18, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820718 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722383 ↗MalfunctionAug 20, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT AND THE LATCH ON BROACH HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849324 ↗MalfunctionJul 31, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT ITEM WON'T STAY LOCKED. LOOSE HANDLE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680664 ↗MalfunctionJul 28, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT CURVED BROACH HANDLE WAS FLOPPY AND DIDN¿T HOLD A BROACH SECURELY. BROACHES WERE AT RISK OF FALLING OFF THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629758 ↗MalfunctionJul 24, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE EXTRA CURVED BROACH HANDLE WAS LOOSE AT THE ATTACHMENT OF THE HANDLE. THE HANDLE WOULD NOT LOCK IN PLACE WHEN A ACT IS BROACH WAS ATTACHED. NOTHING BROKE OFF FROM INSTRUMENT. NO PATIENT HARM OR DELAY IN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587646 ↗MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING DEVICE REPROCESSING, THE STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565228 ↗MalfunctionJul 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED DURING DEVICE REPROCESSING, STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4) WHICH WAS CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554302 ↗MalfunctionJun 23, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE WAS LOOSEN AND NOT HOLDING THE BROACH WHEN IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309191 ↗MalfunctionJun 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH HANDLE WAS NOT LOCKING BROACH IN PROPERLY. THE BROACH HANDLE WOULD NOT CLOSE, IT WAS BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307709 ↗MalfunctionJun 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BOTH EXTRA CURVED BROACH HANDLES WERE USED IN THE CASE, AND BOTH EXTRA CURVED BROACH HANDLES WOULD NOT FULLY ENGAGE THE LOCKING MECHANISM. NO DELAY TO CASE, NO HARM TO PATIENT, AND NO PARTS CAME OFF OF THE EXTRA CURVED BROACH HANDLE. THE SURGICAL TECH AND SURGEON USED THE EXTRA CURVED BROACH HANDLE BY CAREFULLY INSURING NOT TO RELEASE THE HANDLE TO KEEP THE BROACH PROPERLY ENGAGED DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306997 ↗MalfunctionJun 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BOTH EXTRA CURVED BROACH HANDLES WERE USED IN THE CASE, AND BOTH EXTRA CURVED BROACH HANDLES WOULD NOT FULLY ENGAGE THE LOCKING MECHANISM. NO DELAY TO CASE, NO HARM TO PATIENT, AND NO PARTS CAME OFF OF THE EXTRA CURVED BROACH HANDLE. THE SURGICAL TECH AND SURGEON USED THE EXTRA CURVED BROACH HANDLE BY CAREFULLY INSURING NOT TO RELEASE THE HANDLE TO KEEP THE BROACH PROPERLY ENGAGED DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306990 ↗MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BROACH HANDLES WERE NOT LOCKING, SPRING DISENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298600 ↗MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BROACH HANDLES WERE NOT LOCKING, SPRING DISENGAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296909 ↗MalfunctionJun 4, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT HANDLE WAS LOOSE, CAN'T STAY CLAMPED WHEN ATTACHING BROACH. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142859 ↗MalfunctionMay 30, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE LOCKING MECHANISM IS LOOSE. THE DEVICE WILL NOT STAY LOCKED IN PLACE WITH BROACH ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116236 ↗MalfunctionMay 22, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE HANDLE WAS LOOSE ON THE BROACH HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22071629 ↗MalfunctionApr 17, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE HAS LOOSENED AND NO LONGER HOLDS THE BROACH TIGHTLY. THERE WAS NO DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854587 ↗MalfunctionMar 31, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT AN ACTIS EXTRA CURVED ANTERIOR BROACH HANDLE LOCKING MECHANISM WAS NOT FUNCTIONING PROPERLY. HANDLE WAS LOOSE WHEN ATTACHED TO THE BROACH BUT WAS STILL USED DURING SURGERY. NO PIECES BROKE OFF. THERE WAS NO EFFECT ON PATIENT AND NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730872 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROACH HANDLES WOULDN'T LOCK AND WERE LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618269 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROACH HANDLES WOULDN'T LOCK AND WERE LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618267 ↗MalfunctionJan 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM OR ANY REPORTED DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126907 ↗MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE OFFSET BROACH HANDLE WAS NOT ENGAGING.
Patient problems: Insufficient Information
MAUDE report 20834240 ↗MalfunctionOct 25, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PRODUCT DID NOT BREAK INTO 2 OR MORE PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537948 ↗
Other BROACH devices
- 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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