OFFSET FLEX CLAMPING 31-555408 (UDI 00880304522749)Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet orthopedic clamping instrument is used manually during hip surgery to prepare the femoral canal for an implant. The 33 reports mostly describe the broach handle breaking or snapping during broaching, with no effect on the patient noted in any of them. There have been no deaths and no injuries. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00880304522749), received between Oct 11, 2019 and May 18, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Fracture” (33 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture33
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT THE BACK OF THE FEMORAL BROACH HANDLE BROKE DURING BROACHING. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201703 ↗MalfunctionFeb 5, 2026Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268365 ↗MalfunctionFeb 5, 2026Fracture
IT WAS REPORTED THAT THE BROACH HANDLE BROKE WHILE THE SURGEON WAS PREPARING THE FEMORAL CANAL. NO PATIENT HARM OR IMPACT REPORTED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268242 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE THE SURGEON WAS BROACHING THE FEMORAL CANAL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067731 ↗MalfunctionDec 9, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756763 ↗MalfunctionOct 24, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379445 ↗MalfunctionSep 2, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937465 ↗MalfunctionMar 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DISTAL PART OF THE BROACH HANDLE FRACTURED AND IS NO LONGER WELDED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720639 ↗MalfunctionJan 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING IMPACTION, THE HEAD OF THE BROACH HANDLE BROKE OFF. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138187 ↗MalfunctionNov 25, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773164 ↗MalfunctionNov 6, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620177 ↗MalfunctionJun 12, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE BROACHING FEMUR THE CIRCULAR STRIKE PLATE ON THE END OF THE BROACH HANDLE BROKE OFF. IT APPEARS THE WELD FAILED AFTER BEING USED MANY TIMES. NOTHING FELL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19522072 ↗MalfunctionMay 14, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE EXTRACTING THE TRIAL, THE IMPACTION PLATE BROKE OFF THE BROACH HANDLE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309323 ↗MalfunctionMay 8, 2024Fracture; Fracture
IT WAS REPORTED THAT THE WELD ON THE STRIKE PLATE BROKE WHILE BROACHING.THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19272796 ↗MalfunctionMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE STRIKE PLATE BROKE OFF DURING BROACH REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922305 ↗MalfunctionJan 2, 2024Fracture; Fracture
IT WAS REPORTED THAT AS THE SURGEON WAS BROACHING, THE IMPACTION PLATE BROKE OFF. THE NURSES HAD TO LOCATE AND OPEN NEW STERILE BROACH HANDLE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18424318 ↗MalfunctionOct 24, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17996676 ↗MalfunctionOct 24, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995302 ↗MalfunctionSep 6, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17694195 ↗MalfunctionJul 31, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423585 ↗MalfunctionSep 15, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTION PAD OF THE HANDLE WAS BROKEN DURING A PROCEDURE. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15432919 ↗MalfunctionJul 21, 2022Fracture; Fracture
IT WAS REPORTED THE OFFSET BROACH FRACTURED AT THE WELD. NO IMPACT TO THE CASE TIME OR PATIENT. SECOND OFFSET BROACH WAS USED TO FINISH CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15074405 ↗MalfunctionJun 2, 2022Fracture; Fracture
IT WAS REPORTED THE END OF THE BROACH HANDLE BROKE OFF AFTER MULTIPLE STRIKES. SURGEON NOTICED THE STEM INSERTER WAS LOOSE. USED A DIFFERENT HANDLE TO COMPLETE THE CASE. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572577 ↗MalfunctionMay 19, 2022Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14437875 ↗MalfunctionMay 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, WHILE THE SURGEON WAS RASPING IN THE FEMORAL CANAL, THE SURGEON STRUCK THE INSTRUMENT WITH A MALLET AND THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14366037 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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