NA 314.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982188502), received between Dec 4, 2018 and Jul 24, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 2.5 HEX SCREWDRIVER FOUND DAMAGED. THE TIP OF THE SCREWDRIVER WAS TWISTED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592153 ↗
• MalfunctionAug 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THE POWER IS ROUNDED OFF AT THE END OF THE HEX. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049354 ↗
• MalfunctionAug 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE HEX SCREWDRIVER WAS STRIPPED DURING SURGERY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A HEX SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19909618 ↗
• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STERILE PROCESSING STAFF NOTIFIED THAT A DEVICE WAS NOT ABLE TO COUPLE WITH THE QUICK-CONNECT DRIVER HANDLES. THE EVENT OCCURRED AFTER A SURGICAL CASE DURING ROUTINE SET ASSEMBLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693438 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREWDRIVERS WERE STRIPPED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR ONE (1) CANNULATED 2.5 HEXAGONAL SCREWDRIVER SFT THIS IS REPORT 6 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923665 ↗
• MalfunctionMay 4, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, A NAIL WAS INSERTED. WHILE INSERTING SCREWS, THE T-HANDLE KEPT DISENGAGING FROM THE SHORT POWER SHAFT, AND THE INNER CONNECTING ELEMENT BROKE FROM MALLETING. DRIVER 03.045.003 AND RETENTION PIN 03.045.004 ALSO STRIPPED/BROKE IN THE PROCESS OF TIGHTENING THE SCREW WHILE MALLETING. AFTER NAILING, A VA PPFX PROXIMAL FEMUR PLATE WAS POSITIONED DUE TO THE NAIL. THE SCREW INSERTED WITH THE CANNULATED HEX DRIVER WAS STRIPPED DUE TO THE TORQUE OF THE SCREWDRIVER. A HANDLE SWIVEL WRENCH WAS ALSO USED WITH THE ARTICULATING TENSION DEVICE; TWO BROKE OFF DUE TO PRESSURE, SO A SOLID ONE WAS USED INSTEAD. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. CONCOMITANT PRODUCT DETAILS: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN),. UNK - PLATES: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 9 OF 9 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869754 ↗
• MalfunctionDec 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE WIRE STUCK INSIDE CANNULATED SCREWDRIVER. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) CANNULATED 2.5 HEXAGONAL SCREWDRIVER SFT. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13084433 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT LENT THE ORTHO SCREWDRIVER SET TO THE SURGERY CENTER AND UPON PICKING UP THE SET, IT WAS NOTICED THAT THE HEXAGONAL SCREWDRIVER'S TIP WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100947 ↗
• MalfunctionFeb 12, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320051 ↗
• MalfunctionFeb 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318991 ↗
• MalfunctionJan 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PILON PROCEDURE TO TREAT THE FRACTURE, ONE (1) DEPTH GAUGE FOR SCREWS HOOK BROKE OFF, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER POWER SHAFT STRIPPED, ONE (1) STARDRIVE SCREWDRIVER SHAFT HEAD STRIPPED, ONE (1) LOCKING COMPRESSION PLATE HOLE WAS STRIPPED DUE TO INSERTION OF CORTICAL SCREW AND TWO (2) THREADED DRILL GUIDE WERE STRIPPED AND DID NOT LOCK INTO PLATE. SURGICAL PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127651 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET AT FSL UPS LYNDHURST, NJ SITE, IT WAS OBSERVED THAT THE CANNULATED HEXAGONAL SCREWDRIVER SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434932 ↗
• MalfunctionDec 4, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THERE WERE SEVERAL INSTRUMENTS INSPECTED THAT APPEARED TO BE DAMAGED. FOR THE BONE REDUCTION FORCEPS, THE HINGE IS OVERLY TIGHT AND VERY HARD TO OPEN. THE CANNULATED SCREWDRIVER TIP, AND CANNULATED POWER SHAFT TIP BOTH APPEAR TO BE STRIPPED. THE 2.5MM HEX POWER SHAFTS TIPS ALSO BOTH LOOK STRIPPED. EIGHT (8) 2.8MM LOCKING TOWERS WERE INSPECTED BY THE SALES CONSULTANT WHICH APPEARED TO HAVE DAMAGED THREADS. THE T4 STAR DRIVE FOR THE 1.5MM HEADLESS COMPRESSION SCREW SET WAS DAMAGED AND ACCIDENTALLY PLACED INTO THE SHARPS CONTAINER WHERE THE SALES CONSULTANT COULD NOT RETRIEVE IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8130600 ↗