G7 BALL HEX DRIVER FOR INSERTER 010002736Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304926820), received between Jan 27, 2022 and Feb 26, 2026 — 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fracture

  IT WAS REPORTED THAT DURING ACETABULAR CUP IMPLANTATION, THE BALL-NOSE SCREWDRIVER FRACTURED WITHIN THE INSERTER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457674 ↗
• MalfunctionOct 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE HEX DRIVER BROKE. 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 17974793 ↗
• MalfunctionSep 7, 2023Fracture; Fracture

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699158 ↗
• MalfunctionSep 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF THE SCREWDRIVER BROKE. 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 15491436 ↗
• MalfunctionJan 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP PROCEDURE THE CUP INSERTION HANDLE COULD NOT BE LOOSENED FROM CUP. TOMMY BAR WAS USED WITH G7 BALL TIP SCREW DRIVER TO TRY TO RELEASE CUP. G7 BALL DRIVER BROKE AT TIP AND INSERTION HANDLE WAS STILL ATTACHED TO CUP IN PATIENT. WHOLE CONSTRUCT WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED. 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 13367838 ↗

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, Classified
  G7 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 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.