GLOBAL ADVANTAGE 2128-01-850Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295088158), received between Jul 18, 2017 and Nov 18, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO BROKEN PIECES. THE BROACH HANDLE DID NOT POSITIVELY LOCK ONTO THE BROACH. WE HAD ANOTHER SET OF INSTRUMENTS SO NOTHING WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838078 ↗
• MalfunctionJan 30, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE THREADED TIP OF THE UNIVERSAL SLAP HAMMER BROKE OFF INSIDE OF THE TOP OF THE GLOBAL ADVANTAGE+ BROACH HANDLE WHILE TRYING TO REMOVE A PREVIOUSLY IMPLANTED GLOBAL ADVANTAGE STEM. ALL PIECES WERE RETRIEVED. THE SLAP HAMMER WAS NO LONGER FUNCTIONAL AND CAUSED A 1 HOUR DELAY IN THE SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 9649035 ↗
• MalfunctionJun 14, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE THREADED PIECE OF SLAP HAMMER BROKE OFF AND WAS LEFT STUCK IN THE BROACH HANDLE. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8700178 ↗
• MalfunctionFeb 12, 2019Positioning Problem; Positioning Problem

  BROACHES WERE TOO LOOSE WHEN ATTACHED TO BROACH HANDLE. HANDLE EASILY DISENGAGES ON IT'S OWN AND BROACH CAN FALL OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332576 ↗
• MalfunctionJul 10, 2018Naturally Worn; Naturally Worn

  THE SURGEON COULD NOT SCREW IN THE SLAP HAMMER INTO THE BROACH HANDLE DURING THE SURGERY. HAD TO COMPLETE WITH LIKE PRODUCT. THE THREADS APPEAR TO BE WORN AND DEFORMED AND THE BROACH HANDLE NEEDS TO BE REPLACED. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673818 ↗
• InjuryMay 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HUMERAL BROACH HANDLE WAS NOT LOCKING MAKING DIFFICULT TO REMOVE BROACH IN HUMERUS. SURGEON HAD TO FIND AN ADDITIONAL INSTRUMENT TO ASSIST HIM IN REMOVING BROACH. PRODUCT IS BEING RETURNED FOR REPAIR/REPLACE. SURGICAL DELAY: 3-4 MINS.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7553513 ↗
• MalfunctionDec 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT UPON INSPECTION OF THE BROACH HANDLE, IT WAS DETERMINED THAT THE INSTRUMENT WAS NOT WORKING PROPERLY. THE BROACH WILL NOT LOCK IN PLACE ON THE HANDLE, THEREFORE MAKING IT UNUSABLE IN SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128966 ↗
• MalfunctionJul 18, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE INSERTER HANDLE HAS BECOME LOOSE ON BROACHES AND HUMERAL IMPLANTS IN GLOBAL ADVANTAGE SET.

  Patient problems: No Information

  MAUDE report 6720749 ↗