NA 2598-07-360Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS ANTERIOR BROACH HANDLE RIGHT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Tissue Sparing anterior broach handle is a surgical instrument used to shape bone during hip replacement. Its 104 reports, all malfunction reports, mostly describe the handle breaking at its joints or posts, with some pieces missing, and metal shavings preventing sterilization in some cases. There were no deaths and no injuries, and 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
- 104
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10603295148302), received between Feb 8, 2016 and Sep 29, 2026 — classified as 104 malfunctions.
The most frequently reported specific device problem is “Break” (78 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
- Break78
- Scratched Material9
- Unintended Movement7
- Device-Device Incompatibility6
- Entrapment of Device5
- Detachment of Device or Device Component4
- Appropriate Device Problem Term/Code Not Available3
- Crack3
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Consequences Or Impact To Patient30
- Insufficient Information13
- No Information3
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931326 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50023942 ↗MalfunctionJul 9, 2026Inaccurate Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765102 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT SPD WON'T USE/STERILIZE THE BROACH HANDLES DUE TO METAL SHAVINGS FALLING OFF THE HANDLES FROM OVER USE. THERE WAS DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 25664475 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT TOTAL HIP. DURING BROACHING, THE ANTI ROTATION NIPPLE ON THE BROACH HANDLE WAS BROKEN OFF. ALL PIECES WERE FOUND. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272906 ↗MalfunctionJan 13, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE ANT BROACH HANDLE - R HAS THE POST BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054131 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THAT DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THE LOCKING KNUCKLE IN THE MIDSHAFT OF THE BROACH HANDLE WAS BROKEN. ALL PIECES ARE PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898436 ↗MalfunctionDec 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE CENTRAL KNUCKLE ON THE BROACH HANDLE WAS BROKEN WITH A MISSING PIECE. IT IS UNKNOWN WHERE THE PIECE IS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898256 ↗MalfunctionDec 3, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS FRACTURED INTO TWO OR MORE PIECES AT THE JOINT-AREA. IT WAS FOUND IN CSSD. NO ADVERSE PATIENT CONSEQUENCES, NO FRAGMENT ENTERED THE SURGICAL AREA, NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708654 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT DURING A RIGHT TOTAL HIP SURGERY, DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THAT THE MID SECTION ARTICULATING KNUCKLE ON THE OFFSET BROACH WAS BROKEN WITH A MISSING PIECE. IT IS UNKNOWN WHERE THE PIECE WAS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476309 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT THE HANDLE WAS BROKEN UPON IMPACTION. THE LAST MALLET STRIKE RESULTED IN THE HANDLE FALLING TO THE GROUND AND BREAKING THE LOCKING LATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367827 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE OFFSET BROACH HANDLE WAS BROKEN AT THE MIDDLE ARTICULATING KNUCKLE. A PIECE WAS MISSING AND IT IS UNKNOWN WHERE THE PIECE IS AT.
Patient problems: Insufficient Information
MAUDE report 22840768 ↗MalfunctionAug 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE BROACH HANDLE WAS BROKEN IN THE MIDDLE WHERE THE ARTICULATING KNUCKLE IS LOCATED. IT IS UNKNOWN WHERE THE MISSING PIECE IS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725961 ↗MalfunctionJun 26, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT A PIECE OF THE OFFSET BROACH HANDLE BROKE OFF INSIDE THE PATIENT AND THE SURGEON WASN'T ABLE TO RETRIEVER IT.
Patient problems: Foreign Body In Patient
MAUDE report 22337080 ↗MalfunctionJun 11, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE WOULD NOT LOCK ONTO BROACH. THE SQUEEZE HANDLE IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186783 ↗MalfunctionMay 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THAT THE OFFSET BROACH HANDLE WAS BROKEN WITH A MISSING PIECE FROM THE MIDSHAFT KNUCKLE. IT IS UNKNOWN WHERE THE PIECE IS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054613 ↗MalfunctionApr 21, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE CLAMP JOINT WELDS HAVE FAILED AND LOOSENED. THE WHITE PLASTIC T-HANDLE CRACKED AND COULD NO LONGER BE STERILIZED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874770 ↗MalfunctionApr 2, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE INSTRUMENT AS THE RIVETS ON THE LEVER ATTACHMENT COME LOOSE. SEEN IN CSSD. NO ADVERSE PATIENT CONSEQUENCES, NO FRAGMENT ENTERED THE SURGICAL AREA, NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753322 ↗MalfunctionMar 14, 2025Break; Break
IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE BROACH HANDLE WAS BROKEN WITH A MISSING PIECE FROM THE ARTICULATING KNUCKLE ON THE MIDDLE OF THE HANDLE. IT IS UNKNOWN WHERE THE PIECE IS.
Patient problems: Insufficient Information
MAUDE report 21610024 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP. DURING BROACHING OF THE FEMUR, THE OFFSET BROACH HANDLE ANTI-ROTATION TIP/NIPPLE, ON THE END OF THE BROACH, BROKE OFF. THE BROKEN PIECE WAS FOUND IN THE SHOULDER OF THE BROACH ITSELF. NO PIECES WERE MISSING.
Patient problems: Insufficient Information
MAUDE report 21104921 ↗MalfunctionDec 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS NOT CLASPING BROACH.
Patient problems: Insufficient Information
MAUDE report 20906626 ↗MalfunctionNov 5, 2024Break; Break
IT WAS REPORTED THAT THE BROACH HANDLE HAS A PART BROKEN OFF AT THE INSTRUMENT´S JOINT-AREA. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614984 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THIS PATIENT WAS HAVING A RIGHT TOTAL HIP. DURING BROACHING OF THE FEMUR, THE NIPPLE DISTAL TIP OF THE BROACH HANDLE BROKE OFF AND FELL INTO THE FEMUR. IT TOOK 3 MINUTES TO FIND AND RETRIEVE THE PIECE.
Patient problems: Insufficient Information
MAUDE report 20277712 ↗MalfunctionSep 20, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THAT THE OFFSET BROACH HANDLE HAD A BROKEN KNUCKLE IN THE MIDDLE ARTICULATING JUNCTION OF THE INSTRUMENT. IT IS UNKNOWN WHERE THE BROKEN PIECE IS.
Patient problems: Insufficient Information
MAUDE report 20265822 ↗MalfunctionSep 3, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? -> YES, WHEN A PART IS BROKEN OFF THE INSTRUMENT NOW IS IN TWO OR MORE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126258 ↗
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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