NA 312.449Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982187765), received between May 12, 2022 and Jun 16, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, THE DRILL BIT WAS STUCK IN THE DRILL GUIDE AND, AFTER SEVERAL ATTEMPTS TO REMOVE IT, IT WAS NOT ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521978 ↗
• MalfunctionAug 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS BENT AND NOT WORKING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800462 ↗
• MalfunctionAug 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS BENT AND NOT WORKING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800461 ↗
• MalfunctionAug 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS BENT AND NOT WORKING. IT NEED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790221 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610474 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610469 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610462 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610461 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610460 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610455 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610452 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610451 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610450 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610321 ↗
• MalfunctionJun 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 4.3MM THREADED DRILL GUIDE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610319 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT TWO DRILL GUIDE DEVICES NO LONGER THREAD ALL THE WAY ON TO THE PLATES WITH A POSSIBLE "PAINT CHIPPED OFF". THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO(2) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377772 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT TWO DRILL GUIDE DEVICES NO LONGER THREAD ALL THE WAY ON TO THE PLATES WITH A POSSIBLE "PAINT CHIPPED OFF". THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377693 ↗