NA 96-6521Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL BROACH HANDLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295248651), received between Jun 26, 2018 and Jan 12, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device-Device Incompatibility2
- Mechanical Jam2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Mechanical Jam; Mechanical Jam
AFTER KNEE REVISION SURGERY TODAY, THE SPRING MECHANISM OF THE TIBIAL BROACH HANDLE SEEMED TO HAVE BEEN PUSHED OUT OF ALIGNMENT AND BECAME VERY STIFF. THE INSTRUMENT APPEARED TO FUNCTION OK DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18504821 ↗MalfunctionJun 29, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN SURGEON WAS BROTCHING FOR TIME SLEEVE. THE LAST STRIKE OF BROTCHING THE SURGEON NOTICE THAT THE HANDLE DIDN¿T GRIP THE HANDLE. THE DISTAL END OF THE HANDLE HAD BROKEN. WE CONTINUE WITH SURGERY AS NORMAL , THEN THE SURGEON USE GRIP INSTRUMENT AND A STANS AND HAMMER TO EXTRACT THE BROTCHSLEEVE FROM TIBIA. PROLONGED SURGERY 5 MIN. NO MORE INFO / NO IMPACT ON THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 14852335 ↗MalfunctionFeb 7, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
THE HANDLE MECHANISM JAMMED AND IT WAS HARD TO CONNECT TO THE BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476553 ↗MalfunctionJan 30, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT ALL INSTRUMENTS WERE STRIPPED AND NEED TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8288912 ↗MalfunctionJun 26, 2018Break; Break
IT WAS REPORTED THAT THE SIGMA IMPACTOR HANDLE BROKE. NO SURGICAL DELAY. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7638988 ↗
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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