AO Driver Tip 1405-2202Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00853114006624), received between Apr 13, 2023 and Jun 13, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE TIP OF THE DRIVER BROKE OFF AND REMAINED IN THE HEAD OF THE SCREW DURING INSERTION. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED OR ANTICIPATED, A PIECE OF A DRIVER TIP IS NOT INTENDED TO BE IMPLANTED, THEREFORE THE COMPANY HAS CHOSEN TO FILE A MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 22202812 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE DRIVING END OF AN AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED OR ANTICIPATED, A PIECE OF AN AO TIP IS NOT INTENDED TO BE IMPLANTED, THEREFORE THE COMPANY HAS CHOSEN TO FILE A MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 19355731 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT THE DRIVING END OF AN AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED OR ANTICIPATED, A PIECE OF AN AO TIP IS NOT INTENDED TO BE IMPLANTED, THEREFORE THE COMPANY HAS CHOSEN TO FILE A MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 18421973 ↗
• MalfunctionAug 31, 2023Break; Break

  THE AVAILABLE INFORMATION INDICATES THE TIP OF A #8 AO HEXALOBULAR TIPS BROKE OFF IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT'S BONE. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED OR ANTICIPATED, A PIECE OF A #8 AO HEXALOBULAR TIP IS NOT INTENDED TO BE IMPLANTED, THEREFORE THE COMPANY HAS CHOSEN TO FILE A MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 17666551 ↗
• MalfunctionAug 22, 2023Break; Break

  THE AVAILABLE INFORMATION INDICATES THE TIP OF A #8 AO HEXALOBULAR TIP BROKE OFF IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT'S BONE. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 17597088 ↗
• MalfunctionJun 29, 2023Break; Break

  IT WAS REPORTED THAT THE DRIVING END OF AN AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 17227567 ↗
• MalfunctionJun 21, 2023Break; Break

  IT WAS REPORTED THAT THE AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 17170468 ↗
• MalfunctionJun 14, 2023Break; Break

  IT WAS REPORTED THAT THE AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 17124662 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT THE AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 16953257 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED THAT THE DRIVING END OF AN AO DRIVER TIP BROKE OFF AS THE SURGEON WAS INSERTING A SCREW. THE DETACHED PORTION OF THE AO DRIVER TIP WAS RETAINED IN THE HEAD OF A SCREW, WHICH WAS IMPLANTED IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED. ALTHOUGH, THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED. THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 16740349 ↗