NA 952212500FRecalls & reported problems
Depuy (Ireland) · LATERALIZED BROACH HANDLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy lateralized broach handle is a surgical handle that holds broach tools. Reports most often describe handles that are loose, worn or will not lock, and parts that break or move unintentionally. The database holds 244 malfunction reports, with no deaths and no injuries. No recalls name this device, and reports fell over the last year (2) compared with the year before (18).
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
- 245
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 245 adverse event reports that list this exact device (DI 10603295230687), received between Jun 23, 2017 and Sep 28, 2026 — classified as 245 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (120 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 Incompatibility120
- Unintended Movement52
- Structural Problem37
- Break26
- Loose or Intermittent Connection13
- Naturally Worn13
- Appropriate Device Problem Term/Code Not Available11
- Connection Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- No Consequences Or Impact To Patient100
- Insufficient Information14
- No Information7
- No Code Available6
- Not Applicable2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 245 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919275 ↗MalfunctionSep 24, 2026Device-Device Incompatibility
It was reported that the broach handle when connected to a broach is very loose and not tight.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886191 ↗MalfunctionMay 12, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BROACH HANDLE SPRING WAS WORN OUT AND WONT STAY ENGAGED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149776 ↗MalfunctionJul 24, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE ATTACHMENT IS LOOSE AND WON¿T LOCK DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586539 ↗MalfunctionJul 16, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BROACH HANDLES DOESN¿T LOCK X 2. THE ACETABULAR GRATER CRACKED AND RUSTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521002 ↗MalfunctionJul 7, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE CURVED BROACH HANDLE WAS LOOSE AND WILL NOT GRIP THE BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22417953 ↗MalfunctionJul 7, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE CURVED BROACH HANDLE WAS LOOSE AND WILL NOT GRIP THE BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22417809 ↗MalfunctionJun 24, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE WAS LOOSE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323443 ↗MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH HANDLE IS WORN AND WILL NOT HOLD BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299569 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN BROACH HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22298215 ↗MalfunctionJun 13, 2025Structural Problem; Structural Problem
IT WAS REPORTED THE BROACH HANDLE DOES NOT LOCK, LOCKING MECHANISM FAILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202228 ↗MalfunctionJun 12, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT DURING AN ARTHROPLASTY PROCEDURE, BOTH BROACH HANDLES DID NOT LOCK LIKE THEY SHOULD. THEY LOCK BUT WITH LITTLE EFFORT OR WHEN TURNED UPSIDE DOWN, THE HANDLE BECOMES REALLY LOOSE AND CAN COME UNLOCKED EASILY. THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO SURGICAL DELAY. THE BACKUP SET WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192679 ↗MalfunctionJun 12, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT DURING AN ARTHROPLASTY PROCEDURE, BOTH BROACH HANDLES DID NOT LOCK LIKE THEY SHOULD. THEY LOCK BUT WITH LITTLE EFFORT OR WHEN TURNED UPSIDE DOWN, THE HANDLE BECOMES REALLY LOOSE AND CAN COME UNLOCKED EASILY. THERE WERE NO BROKEN OR MISSING PIECES. THERE WAS NO SURGICAL DELAY. THE BACKUP SET WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192678 ↗MalfunctionMay 6, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT HANDLE DIDN'T LOCK INTO PLACE. IT WAS LOOSE.
Patient problems: Insufficient Information
MAUDE report 21971941 ↗MalfunctionApr 4, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE HANDLE CLAMP IS LOOSE. THE SURGICAL DELAY IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21774081 ↗MalfunctionMar 12, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BROACH HANDLE WOULD NOT LOCK. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21585174 ↗MalfunctionDec 11, 2024Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLES WOULD NOT LOCK ON WHEN DEPRESSED. THEY WOULD NOT HOLD BROACHES AND STAY LOCKED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906340 ↗MalfunctionDec 11, 2024Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLES WOULD NOT LOCK ON WHEN DEPRESSED. THEY WOULD NOT HOLD BROACHES AND STAY LOCKED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20905778 ↗MalfunctionDec 2, 2024Break; Structural Problem; Break; Structural Problem
IT WAS REPORTED THAT THE BROACH HANDLES DO NOT LOCK PROPERLY AND ARE BROKEN. THEY NEED TO BE REPLACED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20820407 ↗MalfunctionDec 2, 2024Break; Structural Problem; Break; Structural Problem
IT WAS REPORTED THAT THE BROACH HANDLES DO NOT LOCK PROPERLY AND ARE BROKEN. THEY NEED TO BE REPLACED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20820380 ↗MalfunctionNov 12, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED ON OCTOBER 30, 2024 THAT HANDLE THAT LOCKS THE BROACH ONTO THE HANDLE WAS LOOSE. THE EMPHASYS INSERTER FOR KINCISE WAS STRIPPED, AND KINCISE STOPPED WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663981 ↗MalfunctionOct 31, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE CENTRAL STERILE STAFF IDENTIFIED BROKEN CENTRAL SHAFT IN PINNACLE GREATBATCH OFFSET CUP IMPACTOR, SEVERE WEAR TO CURVED BROACH HANDLE, AND DAMAGED THREADS ON CENTER SHAFT OF THREADED STEM IMPACTORS. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579565 ↗MalfunctionOct 24, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED OF OCTOBER 11, 2024 THAT BOTH CURVED BROACH HANDLES WOULD NOT LOCK IN BROACH AND WAS LOOSE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20529929 ↗MalfunctionOct 24, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED OF OCTOBER 11, 2024 THAT BOTH CURVED BROACH HANDLES WOULD NOT LOCK IN BROACH AND WAS LOOSE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20528829 ↗MalfunctionOct 10, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT ONE OF THESE DRILLS WAS BROKEN INTO TWO PIECES, WHILE THE OTHER WAS BENT TO THE POINT OF UNUSABLE. NO PATIENT CONSEQUENCES RELATED TO ANY OF THESE MISSING DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20423435 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page