OFFSET FLEX CLAMPINGRecalls & reported problems across all models
Biomet Orthopedics, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of OFFSET FLEX CLAMPING by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2019 and May 18, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OFFSET FLEX CLAMPING problems
Device problems
- Fracture35
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient1
OFFSET FLEX CLAMPING models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OFFSET FLEX CLAMPING 31-555408ORTHOPEDIC MANUAL SURGICAL INSTRUMENT33 reports
- Offset Flex Clamping 31-555408ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
Recent OFFSET FLEX CLAMPING adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 23, 2024Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19165915 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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