NA 314.22Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982188694), received between Dec 1, 2020 and Nov 15, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY IN RELATION TO THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20695775 ↗
• MalfunctionJan 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL, THE 3.5 HEX WAS STRIPPED DURING REMOVAL. HEAD WAS BENT. NAIL WAS ALSO REMOVED IN CONJUNCTION, A BACK SLAP WAS USED AND UNABLE TO BE THREADED. AFTER REMOVAL PERFORMED, REVISION ORIF WAS DONE AND THE TIP OF THE 2.7 DRILL GUIDE WAS USED TO HARVEST BONE GRAFT AND WAS BENT IN THE PROCESS. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557157 ↗
• MalfunctionSep 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED AND WILL NOT TURN SCREWS. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17830157 ↗
• MalfunctionSep 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED AND WILL NOT TURN SCREWS. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17830152 ↗
• MalfunctionSep 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED AND WILL NOT TURN SCREWS. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17830151 ↗
• MalfunctionSep 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVERS STRIPPED AND WILL NOT TURN SCREWS. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 3.5 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17830150 ↗
• MalfunctionSep 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, ALL DRIVERS WERE STRIPPED AND WILL NOT TURN THE SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17685334 ↗
• MalfunctionSep 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, ALL DRIVERS WERE STRIPPED AND WILL NOT TURN THE SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17685321 ↗
• MalfunctionSep 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, ALL DRIVERS WERE STRIPPED AND WILL NOT TURN THE SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17684602 ↗
• MalfunctionSep 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AND MONTH IN 2023, ALL DRIVERS WERE STRIPPED AND WILL NOT TURN THE SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17684562 ↗
• MalfunctionOct 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM ATTACHMENTS WERE STUCK TOGETHER AND WOULDN'T SEPARATE. IT WAS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: LARGE QUICK COUPLING - PTS DEVICE (PART# 338.49; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12690428 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT BROKE.. PROCEDURE AND PATIENT INVOLVEMENT WAS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467171 ↗
• MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CUTTER FOR TITANIUM ELASTIC NAILS WAS BROKEN, TWO (2) 2.7MM REAMING ROD PUSHER 450MM LONG AND ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE PIECE WERE BROKEN OFF. WHILE, THE STARDRIVE SCREWDRIVER SHAFT T25 3.5MM HEXAGONAL/SELF-RETAIN AND CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT HEAD WERE STRIPPED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. FRAGMENTS WERE GENERATED AND INSTRUMENTS WERE REMOVED. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928611 ↗