NA 314.23Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886982188700), received between Jan 18, 2017 and Jan 15, 2026 — classified as 6 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CANNULATED 4.0 HEXAGONAL SCREWDRIVER SHAFT BROKE AND WON'T HOLD SCREWS. THERE WAS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085746 ↗
• MalfunctionJan 15, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CANNULATED 4.0 HEXAGONAL SCREWDRIVER SHAFT BROKE AND WON'T HOLD SCREWS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085745 ↗
• MalfunctionDec 4, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A INTRA-OPERATIVE EVENT. THE DRIVER WAS NOT SITTING IN THE SCREW HEADS BECAUSE DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717701 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT HEX DRIVER SHAFT SNAPPED DURING INSERTION OF 7.3 CANNULATED SCREW. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS ALSO NOT KNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555635 ↗
• MalfunctionAug 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE DEPTH GAUGE WAS DAMAGED AND NO LONGER ALLOWS GUIDE WIRES TO SLIDE INSIDE TO GET A MEASUREMENT. ON THE CANNULATED SCREWDRIVER SHAFT, THE TIP OF THE DRIVER WAS SLIGHTLY TWISTED AND NO LONGER RETAINS SCREWS WHEN TRYING TO DRIVE THEM. THERE WAS NO SURGICAL DELAY. SURGEON OPENED A NEW TRAY FOR THE INSTRUMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776173 ↗
• MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED THAT SEVERAL SCREWDRIVERS WERE STRIPPED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378633 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF SCREWDRIVER HEAD BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610789 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF SCREWDRIVER HEAD BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610782 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF SCREWDRIVER HEAD BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610779 ↗
• MalfunctionJan 26, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT IN JANUARY 2024, THE INSTRUMENT RUPTURED. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586305 ↗
• MalfunctionNov 7, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN ORIF OF THE SACROILIAC JOINT ONE OF THE GUIDE WIRES BROKE DURING WIRE REMOVAL. ON THE LEFT SIDE, A SCREW WAS PLACED IN AT THE JUNCTION OF THE SCREW HEAD ENTRY POINT AND THE SCREW HAD TO BE REMOVED FOR THE WIRE TO BE REMOVED. THIS CREATED APPROXIMATELY 30 MINUTES OF SURGICAL DELAY. ON THE RIGHT SIDE, THE SCREWDRIVER TIP BROKE WHILE INSERTING A SCREW. NOT ALL FRAGMENTS GENERATED WERE ABLE TO BE REMOVED. IT WAS SUSPECTED THAT TWO SCREWS FROM OPPOSITE SIDES INTERFERED WITH ONE ANOTHER. NO WIRE FRAGMENTS WERE LEFT BEHIND. THIS REPORT IS FOR A CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083403 ↗
• MalfunctionOct 19, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE NURSING STAFF NOTICED THAT A CANNULATED DRIVER WOULD NOT PASS OVER THE APPROPRIATE GUIDEWIRE DUE TO A SLIGHT DEFORMATION AT THE TIP. A NEW TRAY WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967966 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF SCREW DRIVER IS BENT AND WIRES CAN NOT PASS THROUGH. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17651111 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVER WAS NOT FITTING THE SCREWS. NO PATIENT CONSEQUENCE AND SURGICAL DELAY WAS REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005590 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE DRIVER SHAFT WAS BROKEN. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577155 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TIP OF THE 4.0MM CANNULATED SCREW DRIVER, BROKE OFF IN THE PATIENT AS THE SURGEON WAS IMPLANTING A 7.3MM CANNULATED SCREW. THE DOCTOR REMOVED THE GENERATED FRAGMENTS AND A SECOND SCREW DRIVER WAS OPENED AND USED TO INSERT THE SCREW. THERE WAS A SURGICAL DELAY OF 15 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195267 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, I NOTICED THAT ONE SYNTHES CANNULATED HEXAGONAL SCREWDRIVER SHAFT WAS DAMAGED. THE TIP OF THE POWER SHAFT WAS COMPLETELY BREAK OFF. IT WAS UNKNOWN THAT WHEN THE DAMAGED OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT . THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384047 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE CANNULATED HEXAGONAL SCREWDRIVER SHAFT WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307627 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOLLOWING PRODUCT WAS FOUND BROKEN: ALUMINUM CASE, DEPTH GAUGE, T-HANDLE WITH QUICK COUPLING, TWO CANNULATED HEXAGONAL SCREWDRIVER, AND HEXAGONAL SCREWDRIVER. ATTACHED TO CANNULATED POWER SHAFT IS A LARGE QUICK COUPLING THAT NEEDS TO REPAIR. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER. THIS REPORT IS 4 OF 15 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260753 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE CANNULATED HEXAGONAL SCREWDRIVER SHAFT WHERE THE SCREW ENGAGED BROKE OFF. THERE WAS A ONE (1) MINUTE SURGICAL DELAY. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11437466 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, WHILE INSERTING A SCREW, A CANNULATED HEXAGONAL SCREWDRIVER SHAFT BROKE OFF. A FRAGMENT WAS RETRIEVED AND THE SURGERY WAS COMPLETED BY OPENING ANOTHER SET FOR A SECOND CANNULATED HEXAGONAL SCREWDRIVER SHAFT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR 1 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623059 ↗
• InjuryDec 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS DOING A HIP PINNING WITH 7.3 CANNULATED SCREW AND CANNULATED HEXAGONAL SCREWDRIVER SHAFT BROKE. THE TIP OF THE SCREWDRIVER COMPLETELY BROKE OFF INTO THE PATIENT UPON SCREW INSERTION. THERE WERE SMALL FRAGMENTS OF METAL IN THE PATIENT. ALL FRAGMENTS WERE FOUND AND THIS WAS CONFIRMED ON X-RAY. THE SURGEON RETRIEVED ALL PIECES AND NO METAL FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. IT IS UNKNOWN HOW LONG THE SURGERY DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CANNULATED SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) CANNULATED 4.0 MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9445475 ↗
• MalfunctionOct 14, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2019, THE TIP OF THE CANNULATED HEXAGONAL SCREWDRIVER SHAFT BROKE OFF INSIDE THE SCREW HEAD WHILE INSERTING AN UNKNOWN SCREW. THE SURGEON USED A FLUORO TO TAKE OUT THE SCREW. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REINSERTING A NEW SCREW. THERE WAS A 20 MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1)CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9185112 ↗
• MalfunctionSep 9, 2019Break; Break

  IT WAS REPORTED THAT ON AUGUST 12, 2019, THE CANNULATED HEXAGONAL POWER SCREWDRIVER TO THE 6.5 MM CANNULATED SCREWS BROKE AT THE TIP DURING A PELVIS RECONSTRUCTION CASE. ALSO, THE 2.5 HEXAGONAL CONICAL EXTRACTOR WAS STRIPPED DURING THE POLY TRAUMA PROCEDURE. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THERE WAS NO OTHER REQUIRED MEDICAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN 6.5 MM CANNULATED SCREWS (PART# UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 FOR 2 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974872 ↗
• MalfunctionAug 7, 2019Crack; Crack

  IT WAS REPORTED ON (B)(6) 2019, ONE (1) HEX FLEXIBLE SCREWDRIVER, ONE (1) HEXAGONAL SCREWDRIVER SHAFT, AND ONE (1) HEXAGONAL SCREWDRIVER BROKE AND IT WAS OBSERVED THE DISTAL TIP OF THE CANNULATED 4.0 MM HEXAGONAL SCREWDRIVER SHAFT IS CRACKED AS MENTIONED BY THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) CANNULATED 4.0 MM HEXAGONAL SCREWDRIVER SHAFT THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8871758 ↗