G7 110018822Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Quick summary
This Biomet Orthopedics positioning guide rod is a hand-held surgical instrument used during orthopedic procedures such as hip surgery. Most of the 50 reports describe the rod's tip snapping off or breaking while in use, in a few cases leaving a piece behind in the patient or turning up on the operating table instead. Reports mention 1 injury and no deaths. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00880304676992), received between Apr 28, 2021 and Sep 25, 2026 — classified as 1 injury, 50 malfunctions.
The most frequently reported specific device problem is “Fracture” (49 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
- Fracture49
- Detachment of Device or Device Component1
- Difficult to Insert1
- Material Deformation1
- Naturally Worn1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fracture
It was reported, when disassembling the radar from the green/black G7 inserter handle, the tip of the key snapped. No patient involvement reported. No additional information available for the reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897314 ↗MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT THE TIP OF A POSITIONING GUIDE ROD BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512445 ↗MalfunctionSep 30, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178316 ↗MalfunctionSep 2, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938232 ↗MalfunctionMay 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE POSITIONING GUIDE ROD WAS FOUND FRACTURED DURING USE. THERE WAS NO DELAY TO THE PATIENT AS THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT USING THE DEVICE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002152 ↗MalfunctionMar 3, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT THE POSITIONING GUIDE ROD WAS BROKEN AND THAT THE COMPONENTS WERE UNBALANCED WHEN ASSEMBLED TOGETHER. 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 21503955 ↗MalfunctionJan 2, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21054468 ↗MalfunctionOct 28, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544808 ↗MalfunctionSep 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A RIGHT HIP SURGERY, THE TIP OF THE POSITIONING GUIDE ROD WAS NOTICED TO BE BROKEN. THE TIP WAS FOUND ON THE BACK OPERATING ROOM TABLE AND WAS NOT IN THE PATIENT. A BACKUP INSTRUMENT WAS AVAILABLE AND THERE WAS NO SURGICAL DELAY, NO PATIENT IMPACT, AND NO REPORTS OF FOREIGN BODY RETENTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301342 ↗MalfunctionSep 17, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236536 ↗MalfunctionSep 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE GUIDE ROD BROKE WHEN TRYING TO UNSCREW. THERE WAS NO PATIENT IMPACT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20231015 ↗MalfunctionSep 11, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190054 ↗MalfunctionJul 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE ALIGNMENT PIN WAS BROKEN BY SCRUB NURSE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19743094 ↗MalfunctionJul 15, 2024Naturally Worn; Positioning Problem; Naturally Worn; Positioning Problem
IT WAS REPORTED THAT THE POSITIONING GUIDE RODS HAVE BEEN AFFECTED BY THE SCREWING SO THE METAL END IS WORN AND DOES NOT CONTACT WELL WITH THE IMPACTOR AS INTENDED. THE GUIDE RODS KEEP FALLING ON THE SIDE INSTEAD OF STAYING CONNECTED TO THE IMPACTOR. 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 19742222 ↗MalfunctionJul 1, 2024Fracture; Fracture
IT WAS REPORTED THE POSITIONING GUIDE ROD WAS HIT WITH A MALLET DURING A SURGERY AND AS A RESULT IT BROKE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19642785 ↗MalfunctionMay 15, 2024Fracture; Fracture
IT WAS REPORTED THE HEAD OF THE POSITIONING GUIDE ROD BROKE OFF. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19318593 ↗MalfunctionApr 30, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE ASSEMBLING THE CUP INSERTER, THE GUIDE PIN WAS FOUND TO BE BROKEN. 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 19215640 ↗MalfunctionMar 21, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GUIDE ROD WAS PLANNED TO BE USED FOR A PROCEDURE HOWEVER IT WAS NOTICED THAT THE THREADING ON THE ROD WAS NOT GOING TO ENABLE THEM TO USE THE INSTRUMENT SUCCESSFULLY. 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 18952224 ↗InjuryMar 5, 2024Fracture; Fracture
IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPACTING THE G7 CUP, THE POSITIONING GUIDE FELL FROM THE CURVED IMPACTOR AND THE SURGEON AND NURSE NOTICED THAT THE TIP OF THE GUIDE ROD WAS BROKEN. A SMALL PIECE FELL ON THE PATIENT (NOT INSIDE) AND WAS RETRIEVED. ANOTHER VERY SMALL PIECE IS STILL MISSING AND WAS UNABLE TO BE LOCATED WITH A POSSIBILITY OF LANDING INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 18836461 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE IMPACTING THE CUP, THE BOTTOM OF THE POSITIONING PIN BROKE. THE TIP OF THE STRAIGHT ACETABULAR SHELL INSERTER ALSO BROKE WHILE REMOVING THE LINER IMPACTOR HEAD. THERE WAS NO PATIENT IMPACT, NO MEDICAL OR SURGICAL INTERVENTIONS, NO SURGICAL DELAY, AND NO FOREIGN BODY RETAINED. SURGICAL TECHNIQUE WAS UTILIZED. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825650 ↗MalfunctionJan 30, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607375 ↗MalfunctionJan 22, 2024Fracture; Fracture
IT WAS REPORTED THE NURSE WAS ASSEMBLING THE CUP IMPACTOR AND THE ROD FRACTURED WHEN SCREWED IN. THE EVENT OCCURRED BEFORE SURGERY. NO KNOWN 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 18553088 ↗MalfunctionDec 22, 2023Fracture; Fracture
IT WAS REPORTED THAT THE GUIDE ROD WAS BROKEN. 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 18382886 ↗MalfunctionDec 14, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE DEVICE THAT SECURES THE ALIGNMENT GUIDE ONTO THE G7 CURVED CUP IMPACTOR BROKE AT THE TIP WHEN IT IS TIGHTENED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18329042 ↗MalfunctionDec 11, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18302663 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.