NA 2598-07-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10603295148296), received between Aug 8, 2017 and Sep 9, 2026 — classified as 94 malfunctions.

The most frequently reported specific device problem is “Break” (71 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698096 ↗
• MalfunctionJul 9, 2026Inaccurate Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764987 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT DURING REASSEMBLY OF THE INSTRUMENTS, THE OFFSET BROACH HANDLE WAS FOUND TO BE BROKEN AT THE ARTICULATING JUNCTION IN THE MIDDLE OF THE HANDLE. A PIECE IS MISSING AND IT IS UNKNOWN WHERE IT IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518067 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL HIP. DURING BROACHING, THE MIDSHAFT KNUCKLE ON THE OFFSET BROACH HANDLE BROKE INTO PIECES. ALL PIECES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400787 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE STUD BROKE OFF THE END OF THE BROACH HANDLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334655 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT WHEN REMOVING BROACH FROM BROACH HANDLE, THE SMALL NUB CAME OFF. PIECE WAS FOUND & REMOVED FROM THE FIELD & THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958556 ↗
• MalfunctionDec 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THE MID SHAFT LOCKING KNUCKLE OF 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 23769865 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT THE OFFSET BROACH HANDLE BROACH STABILIZER BROKE OFF THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745336 ↗
• MalfunctionOct 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE BROACH HANDLE AT THE MID ARTICULATING JUNCTION WAS BROKEN WITH A MISSING PIECE. IT IS UNKNOWN WHERE THE PIECE IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393137 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS BROKEN ANGULATION INSIDE THE BROACH HANDLE. SAME LIKE DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963973 ↗
• MalfunctionJul 11, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE OFFSET BROACH HANDLE WAS CRACKED AT THE ARTICULATING JUNCTION MIDSHAFT ON THE HANDLE. ALL PIECES WERE PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479338 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT STABILIZER TIP OF HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473764 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE SURGICAL TECH WAS LOADING A BROACH ON, AN INTERNAL PIECE OF METAL FELL OUT. THERE WAS NO HARM DONE TO PATIENT, ALL BROKEN PIECES WERE RETRIEVED, NO DELAY OCCURRED, NO PERSON WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358738 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED DURING A TOTAL HIP PROCEDURE THE TIP OF THE INSTRUMENT HAS BROKEN OFF DURING USE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202801 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT THE BROACH HANDLE TIP BROKE OFF. ALL PIECES WERE LOCATED AND MOVED OFF THE FIELD. THERE WAS NO DELAY IN CASE, NO HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140482 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM FRACTURED INTO TWO OR MORE PIECES AT THE JOINT-AREA. SEEN IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO ADVERSE PATIENT CONSEQUENCE, NO FRAGMENT ENTERED THE SURGICAL AREA, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604861 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT LEFT BROACH HANDLE WAS BEING IMPACTED WHEN THE SMALL METAL TIP ON THE END ATTACHED TO THE BROACH, BROKE OFF. THE PIECE WAS REMOVED FROM THE PATIENT AND THE FIELD. THERE WAS NO DELAY IN THE CASE OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582974 ↗
• MalfunctionFeb 7, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS IS A PRE OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338215 ↗
• MalfunctionDec 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE OFFSET BROACH HANDLE HAS A BROKEN AND MISSING PIECE AT THE MIDDLE ARTICULATING KNUCKLE. IT IS UNKNOWN WHERE THE PIECE IS AT.

  Patient problems: Insufficient Information

  MAUDE report 20912807 ↗
• MalfunctionDec 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE IS NOT CLASPING BROACH.

  Patient problems: Insufficient Information

  MAUDE report 20906485 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT LEFT DUAL OFFSET BROACH HANDLE BROKE. ALL PIECES WERE RECOVERED. THERE WAS NO DELAY TO CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538756 ↗
• MalfunctionSep 3, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT BECAUSE OF THE REPORTED EVENT. B. IF DEPUY SYNTHES INSTRUMENTATION BROKE DURING SURGERY, WERE ALL PIECES RETRIEVED FROM THE PATIENT? -WE HAVE NO INFORMATION THAT THE PIECE IS STILL IN THE PATIENT. C. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, HOW LONG? -NO SURGICAL TIME EXTENDED DUE TO THE EVENT. D. DID THE INSTRUMENT BREAK INTO TWO OR MORE PIECES? -TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125129 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS NOTICED THAT THE ARTICULATING KNUCKLE ON THE MIDSHAFT OF THE BROACH HANDLE HAS A BROKEN PIECE THAT IS MISSING. IT IS UNKNOWN WHERE THE PIECE IS LOCATED. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20084861 ↗
• MalfunctionApr 1, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE BROACH HANDLES LOCKING MECHANISMS HAVE BECOME LOOSE AND OPEN ON THEIR OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012336 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT ALL THE REAMERS WERE JUST DULL THROUGH NORMAL WEAR AND TEAR. ALSO, WHERE THEY ATTACH TO THE BLACK HANDLE REAMER, IT CAN BE SEEN CLEARLY THAT THERE ARE DIVETS DUE TO THE SURGEON FORCEFULLY REAMING. THE BROACH HANDLES WERE BROKEN FROM THE SURGEON HITTING THEM. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937263 ↗