G7 STRAIGHT MODULAR SCREWDRIVER 010002749Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304926912), received between Jun 17, 2022 and Oct 27, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 reports).
3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.
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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391942 ↗MalfunctionJul 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER FRACTURED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629537 ↗MalfunctionJul 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE CURVED INSERTER THREADED SHAFT SCREW BROKE WHILE TRYING TO DISENGAGE THE INSERTER HANDLE FROM THE ACETABULAR CUP IMPLANT WHILE IT WAS IN THE PATIENT. THE SURGEON REMOVED THE CUP FROM THE PATIENT AND IMPLANTED A NEW CUP. THE SCREWDRIVER WAS RETURNED FRACTURED AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE EVENT/FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22620804 ↗MalfunctionFeb 1, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER THE PROCEDURE THE SCREWDRIVER WAS FOUND TO BE BROKEN WITH THE TIP BROKEN OFF INSIDE THE BLACK SET SCREW. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622678 ↗MalfunctionJun 17, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14731617 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.
- Z-0007-2023 · Aug 25, 2022 · Open, ClassifiedG7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Z-1837-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Other prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive devices
- G7® Acetabular System 010000665Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive31 reports
- G7® 110003450Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive29 reports
- G7® Acetabular System 110010244Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive24 reports
- G7® Acetabular System 110010263Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive11 reports
- G7® Acetabular System 110010266Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7 CURVED INSERTER THREADED SHAFT 110003454Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7® 110010717Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 OSSEOTI ACETABULAR SHELL 110010265Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 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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