REUNION 5901-1122Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327100303), received between Nov 27, 2019 and Feb 3, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 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 3, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON WAS USING THE CENTER SCREW T25 DRIVER (5901-1122) ON A LARGE T HANDLE (1101-2100) PUTTING THE CENTER SCREW INTO THE BASEPLATE. WHILE TURNING IN THE CENTER SCREW T25 DRIVER IN THE CENTER SCREW THE TIP OF THE SCREW DRIVER BROKE OFF IN THE CENTRAL SCREW. THE SURGEON TRIED USING A BURR TO REMOVE THE BROKEN TIP AND FORCEPS BUT WAS UNABLE TO. THE CENTER SCREW T25 DRIVER WAS NO LONGER NEEDED TO COMPLETE THE SURGERY AND WAS REMOVED FROM THE CONSIGNMENT SET.". 30 MINUTES SURGICAL DELAY TO USE A BUR TO TRY TO GET IT OUT OF THE SCREW AND A VICE GRIP. EVENT OCCURRED DURING A PRIMARY SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16291974 ↗
• MalfunctionMay 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS USING THE CENTER SCREW T25 DRIVER ON A LARGE T HANDLE PUTTING THE CENTER SCREW INTO THE BASEPLATE. WHILE TURNING THE CENTER SCREW T25 DRIVER THE TIP OF THE SCREW DRIVER BROKE OFF IN THE CENTRAL SCREW. THE SURGEON ATTEMPTED TO REMOVE THE TIP OF THE SCREW DRIVER, BUT IT WAS FIXATED IN THE CENTRAL SCREW. THE SURGEON THEN CONTINUED WITH THE SURGERY AND IMPACTED THE GLENOSPHERE. THE CENTER SCREW T25 DRIVER WAS NO LONGER NEEDED TO COMPLETE THE SURGERY AND WAS REMOVED FROM THE CONSIGNMENT SET AT (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 14317289 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT WHILE DRIVING THE CENTRAL SCREW, THE TIP OF THE T25 DRIVER BROKE IN THE SCREW. THE TIP WAS RETRIEVED, DEVICE REASSEMBLED AT BACK TABLE, AND PATIENT WAS IRRIGATED TO ENSURE THAT ALL PIECES WERE REMOVED FROM THE PATIENT. A SECOND DRIVER WHICH WAS ALREADY AVAILABLE IN THE O.R. WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9786117 ↗
• MalfunctionDec 2, 2019Break; Break

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT WHILE INSERTING A SCREW, THE TIP OF THE T25 STAR DRIVER BROKE OFF IN THE SCREW. THE PIECE WAS RETRIEVED, PATIENT WAS VISUALLY INSPECTED AND IRRIGATED TO ENSURE NO PIECES REMAINED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9394940 ↗
• MalfunctionNov 27, 2019Break; Break

  IT WAS REPORTED THAT HOSPITAL STAFF GAVE THE REP A T25 SCREWDRIVER WITH A BROKEN TIP AND REPORTED IT HAD BROKEN ON (B)(6) 2019 DURING A REVERSE SHOULDER PROCEDURE. REP WAS NOT PRESENT FOR THE PROCEDURE AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387542 ↗