Exact™ 31-555500Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868482472), received between Nov 17, 2023 and Feb 26, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A HANDLE WAS SPILLED AND RETURNED TO THE WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE DEVICE LATER FOUND FRACTURING AND OTHER PHYSICAL DAMAGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24460953 ↗MalfunctionSep 10, 2025Fracture; Loose or Intermittent Connection; Naturally Worn; Fracture; Loose or Intermittent Connection; Naturally Worn
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018735 ↗MalfunctionApr 29, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201358 ↗MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ENDOPROSTHESIS OF THE HIP PLASTY, THE RASP FEEDER DISINTEGRATED. THE PIN LOCKING THE RASP FELL OUT AND IT IS NOT POSSIBLE TO WORK ON THE FEEDER. THERE WAS A SHORT DELAY OF FIFTEEN (15) MINUTES AND THE CASE WAS COMPLETED USING ANOTHER SET OF TOOLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161710 ↗
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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