EXACT(TM) OFFSET BROACH HANDLE 31-555501Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00880304432260), received between Nov 25, 2019 and Aug 21, 2025 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture15
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861792 ↗MalfunctionJul 18, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22541733 ↗MalfunctionDec 13, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR BROKE WHEN THE SURGEON STRUCK IT. ANOTHER IMPACTOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317221 ↗MalfunctionApr 13, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16733537 ↗MalfunctionMar 10, 2023Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE BROACH HANDLE INSTRUMENT WOULD NOT PROPERLY HOLD THE RASP INSTRUMENT. UPON EVALUATION OF THE INSTRUMENT, THE HANDLE WAS FOUND TO BE FRACTURED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521122 ↗MalfunctionMar 2, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16466571 ↗MalfunctionNov 2, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A HIP PROCEDURE, WHILE THE SURGEON WAS BROACHING FOR THE STEM, THE BROACH HANDLE BROKE. THERE WAS NO HARM OR INJURY TO THE PATIENT. 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 15713918 ↗MalfunctionSep 27, 2022Fracture; Fracture
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15493779 ↗MalfunctionApr 6, 2022Fracture; Fracture
IT WAS REPORTED THE BROACH HANDLE SNAPPED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 14020758 ↗MalfunctionAug 10, 2021Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENTS WERE FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12301990 ↗MalfunctionSep 28, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10597127 ↗MalfunctionSep 3, 2020Fracture; Fracture
IT WAS REPORTED RASP HANDLE IMPACT PLATE FRACTURED OFF. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10491816 ↗MalfunctionSep 3, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10491813 ↗MalfunctionJan 31, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9653167 ↗MalfunctionJan 29, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9643653 ↗InjuryNov 25, 2019Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 9370987 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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