REUNION 5901-1120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327099454), received between Aug 28, 2019 and Apr 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON REMARKED THAT THE UNIVERSAL SCREWDRIVER HANDLE (5901-1120) FELT LIKE SOMETHING WAS BROKEN INSIDE THE HANDLE AND WAS TWISTING. IT WAS DECIDED TO USE THE SECOND HANDLE IN THE HUMERAL 3 TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214948 ↗
• MalfunctionAug 28, 2019Component Missing; Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A SHOULDER REVISION PROCEDURE, IT WAS DISCOVERED THAT THE STRIKE PLATE WAS MISSING FROM THE DEVICE. THE PATIENT AND OPERATING ROOM WERE INSPECTED AND THE STRIKE PLATE WAS NOT FOUND. IT IS UNKNOWN IF THE STRIKE PLATE WENT MISSING DURING THE PROCEDURE, OR PRIOR TO THE PROCEDURE (PRIOR PROCEDURE OR SPD). THE SURGEON ELECTED TO CONTINUE USING THE DEVICE, REQUIRING ADDITIONAL MALLET STRIKES. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE 2 MINUTE DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8941794 ↗