Alliance® SBGL3701Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024575202), received between May 13, 2021 and May 29, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Fracture

  IT WAS REPORTED THAT A PORTION OF THE AUGMENT REAMER DRIVER FRACTURED INSIDE THE PATIENT DURING A PROCEDURE. AN ADDITIONAL INCISION WAS MADE IN ORDER TO REMOVE THE FRACTURED PORTION. ATTEMPTS HAVE BEEN MADE AN NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25331779 ↗
• MalfunctionMay 22, 2026Fracture

  IT WAS REPORTED THAT DURING REAMING FOR AN AUGMENT, THE TIP OF THE REAMER DRIVER SHEARED OFF INTO THE AUGMENT REAMER. DURING INTRA-OPERATIVE PREPARATION, WHILE THE SURGEON WAS REAMING FOR AN AUGMENT, THE OFF-AXIS REAMER TIP FRACTURED AND REMAINED WITHIN THE AUGMENT REAMER ASSEMBLY. THE SURGEON HAD COMPLETED THE REAMING PORTION AND WAS ABLE TO FINISH THE CASE AS PLANNED. THERE WAS 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 25256116 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT THE BALL HEX REAMER DRIVER WAS FRACTURED DURING A PROCEDURE. NO PATIENT IMPACT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743094 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT DURING GLENOID AUGMENT REAMING THE TIP OF A BALL HEX AUGMENT REAMER BROKE. THE EVENT OCCURRED INTRA-OPERATIVELY; ALL FRAGMENTS WERE RETRIEVED, AND A NEW INSTRUMENT TRAY WAS OPENED TO REPLACE THE BROKEN INSTRUMENT AND PROCEED. 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 24650147 ↗
• MalfunctionJan 6, 2026Fracture

  IT WAS REPORTED THAT THE ROUNDED HEX TIP OF A REAMER DRIVER BROKE AS THE SURGEON FINISHED REAMING FOR A GLENOID AUGMENT. THE EVENT OCCURRED INTRA-OPERATIVELY DURING GLENOID PREPARATION; THE DRIVER WAS USED WITH POWER, WHICH WAS BELIEVED TO HAVE CONTRIBUTED TO THE BREAKAGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975472 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE REAMER SNAPPED WHILE REAMING FOR THE AUGMENTED ALLIANCE IMPLANTS. NOTHING FELL INTO THE PATIENT AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621901 ↗
• MalfunctionJul 21, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560490 ↗
• MalfunctionJun 24, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319665 ↗
• MalfunctionJun 9, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966307 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE OFF AXIS REAMER HIT THE DELTOID RETRACTOR WHILE REAMING ON POWER. CAUSED THE OFF AXIS DRIVER HEAD TO SNAP OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871946 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821097 ↗