SQUARE DRIVER 231200101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304533516), received between Mar 8, 2022 and Dec 31, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A DRIVER WAS FRACTURED WITHIN A SCREW HEAD DURING A PROCEDURE. IT WAS UNABLE TO BE REMOVED AND WAS RETAINED BY THE PATIENT. AS THE PATIENT IS QUITE YOUNG, A REMOVAL MAY BE PLANNED IN THE FUTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23934489 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND TO BE FRACTURED BEFORE THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643376 ↗
• InjuryApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A LEFT DISTAL RADIUS FRACTURE, THE SCREWDRIVER TIP BROKE OFF INSIDE THE PROXIMAL LOCKING SCREW. NO INTERVENTION HAS BEEN REPORTED. THE FRACTURED PIECE HAS BEEN RETAINED IN THE PATIENT BODY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16665551 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE 1.7 SQUARE DRIVER FRACTURED DURING SCREW INSERTION. 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 15102552 ↗
• MalfunctionJun 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF WHILE INSTALLING THE 2.7MM CORTICAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754722 ↗
• MalfunctionMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THE SCREWDRIVER SOCKET DOES NOT FIT INTO SCREW HEAD. IT WAS REPORTED ATTACHMENT IS TOO BIG AND MISSING GRADATION. THE PRODUCT WAS RETURNED FRACTURED. 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 13693122 ↗