NA 1806-0233Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04546540520425), received between Mar 16, 2018 and Sep 30, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953382 ↗
• MalfunctionAug 19, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING INSPECTION IT WAS FOUND THAT THE SCREWDRIVER HEAD WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840659 ↗
• MalfunctionMar 14, 2025Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "INSTRUMENT FROM KIT T2 FEMUR ARRIVED WITH BLOOD FROM PREVIOUS SURGERY. THIS ISSUE WAS NOTICED BY STRYKER SALES REPRESENTATIVE BEFORE THE SURGERY, WHEN CHECKING THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609867 ↗
• MalfunctionMar 14, 2025Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "INSTRUMENT FROM KIT T2 FEMUR ARRIVED WITH BLOOD FROM PREVIOUS SURGERY. THIS ISSUE WAS NOTICED BY STRYKER SALES REPRESENTATIVE BEFORE THE SURGERY, WHEN CHECKING THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609863 ↗
• MalfunctionNov 22, 2024Break; Fracture; Break; Fracture

  A BROKEN SCREWDRIVER WAS REPORTED, PER RECEIVED PICTURE THE BLADE / SELF-HOLDING FEATURE AT THE TIP OF THE SCREWDRIVER IS COMPLETELY BROKEN OFF. PATIENT, END USER OR SURGERY IMPACT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20762112 ↗
• MalfunctionAug 6, 2024Break; Fracture; Break; Fracture

  THE SCREWDRIVER HAS BROKEN OFF AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916534 ↗
• MalfunctionJul 1, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "LOCKING SCREWDRIVER FOR TIBIA T2 SYSTEM CAME FRACTURED TO THE SURGERY ROOM. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642860 ↗
• MalfunctionJun 18, 2024Crack; Material Deformation; Material Twisted/Bent; Crack; Material Deformation; Material Twisted/Bent

  AS REPORTED: "TIP OF THE SCREAM TURNER IS CLEARLY BENT. CRACK IN THE MATERIAL AFTER USE.NO PATIENT HAS ANY TROUBLE AND THE OPERATION WAS ENDED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563441 ↗
• MalfunctionMay 31, 2024Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "INSTRUMENT CLEANLINESS: A. AN UNKNOWN PIN ~3.2 X 290MM WAS FOUND INSIDE THE OPENING REAMER (2351-6113). IT WAS COMPLETELY EMBEDDED AND JAMMED INSIDE THE REAMER. THE PIN, ALONG WITH THE REAMER LUMEN, WERE COVERED WITH DRY BLOOD/ TISSUE AFTER MANUAL REMOVAL IN SSU. B. A LONG SCREWDRIVER 3.5MM (1806-0233) WAS INSIDE THE SCREWDRIVER SLEEVE (AS A 2-PART INSTRUMENT). WHEN THE 2 PARTS WERE SEPARATED, THE SCREWDRIVER SHAFT AND THE SCREWDRIVER SLEEVE'S LUMEN WERE ALSO COVERED WITH DRY BLOOD/ TISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19435581 ↗
• MalfunctionMay 7, 2024Break; Fracture; Break; Fracture

  A DEFECTIVE SELF-HOLDING SCREWDRIVER WAS REPORTED. THE TIP WAS PARTIALLY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19263492 ↗
• MalfunctionMar 14, 2024Material Discolored; Material Discolored

  AS REPORTED: "DISCOLORATION OF THE SURFACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908605 ↗
• MalfunctionFeb 16, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727689 ↗
• MalfunctionFeb 9, 2024Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  AS REPORTED: "DURING THE OPERATION WITH DR (B)(6). ON (B)(6) 2023, A PIECE OF THE SELF-TAPPING SCREWDRIVER BECAME DETACHED. THE PIECE WAS RECOVERED BY THE OPERATING ASSISTANT" THERE WAS A 15 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677631 ↗
• MalfunctionDec 21, 2023Use of Device Problem; Use of Device Problem

  AS REPORTED: "INSTRUMENT NO LONGER HOLDS THE 5MM BOLTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370758 ↗
• MalfunctionNov 23, 2023Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "AT THE END OF AN OPERATION ON A 23-YEAR-OLD PATIENT FOR A RIGHT-SIDED TIBIA NAIL (OPEN FRACTURE FOLLOWING MVA), THE SCREWDRIVER BROKE WHEN THE SURGEON TRIED TO EXTRACT A PLUG WHICH HAD BECOME STUCK IN THE NAIL. UNABLE TO FIT A SECOND PLUG, THE SECOND SCREWDRIVER BECAME DISLOCATED. NO PLUG COULD BE FITTED. ALL SCREWDRIVER PARTS WERE RECOVERED AND CHECKED BY THE SURGEON. LONGER OPERATING TIME (30 MIN). NO OTHER CONSEQUENCES FOR THE PATIENT. RISK OF FOREIGN BODY LOSS IN THE SURGICAL SITE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18199335 ↗
• MalfunctionNov 14, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132620 ↗
• MalfunctionSep 28, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THE DISTAL PART OF THE SCREWDRIVER BROKE DURING SCREW INSERTION. A REPLACEMENT WAS AVAILABLE IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540026 ↗
• InjuryMar 15, 2021Fracture; Fracture

  THE SURGEON REPORTED THAT A GAMMA NAIL WAS IMPLANTED IN (B)(6) 2020 AND THE PATIENT PRESENTED WITH A FOREIGN BODY. THE PATIENT WAS REVISED ON (B)(6) 2021 AND THE SURGEON REPORTED THAT THE FOREIGN BODY IS THE TIP OF A GAMMA 3 LOCKING (EXPANDABLE) SCREW DRIVER. THE SURGEON REPORTED THAT THE UNINTENDED METAL WAS FOUND AT THE TOP OF THE PATIENT'S FEMUR. PATIENT REQUIRED REOPERATION SURGERY TO REMOVE THE BROKEN TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 11481647 ↗
• MalfunctionJul 22, 2020Crack; Crack

  IT WAS REPORTED THAT THE DRIVER CRACKED DURING A T2 ANKLE ARTHRODESIS PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10308715 ↗
• MalfunctionOct 8, 2019Material Separation; Component Missing; Material Separation

  PRIMARY PROCEDURE, TIBIA IM NAIL. IT WAS REPORTED THAT THE T2 SELF RETAINING SCREWDRIVER BROKE DURING SURGERY. AFTER CLEANING, THE TIP THAT RETAINS THE SCREW WAS FOUND MISSING (THE TIP WAS IN PLACE PRIOR TO CLEANING, REP CONFIRMED NO PIECES OF THE INSTRUMENT REMAIN IN THE PATIENT). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9165925 ↗
• MalfunctionApr 4, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT, DURING GAMMA SURGERY, SCREW DRIVERS WERE BROKEN. DISCOVERY WAS MADE UPON INSPECTION AFTER THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY A ONE MINUTE DELAY. NO FURTHER INFORMATION PROVIDED FROM THE HOSPITAL OR THE SURGEON. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483033 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING CASE THE LIP ON THE END OF THE T2 SHORT SELF HOLDING SCREWDRIVER WHICH HOLDS THE SCREW IN, BROKE OFF. IT IS UNKNOWN ON INTAKE WHETHER ANY UNINTENDED METAL FELL INTO THE PATIENT. BOTH SCREW DRIVERS GOT DAMAGED AT THE SAME CASE. 20TH FEB. WAS THE OP DATE. THERE WERE NO DAMAGED ITEMS IN THE PATIENT ACCORDING TO HIM. THERE WERE NO DELAYS TO THE OPERATION AS THERE ARE SPARE STANDARD SCREWS DRIVERS IN THE SET WHICH CAN ALSO BE USED INSTEAD OF THE SELF-HOLDING SCREW DRIVERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445007 ↗
• MalfunctionOct 18, 2018Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE HEX OF THE SCREWDRIVER ROUNDED AS THE SURGEON USED IT TO TURN THE SCREW. THE PATIENT¿S BONE WAS VERY HARD AND THIS MAY HAVE MADE IT MORE DIFFICULT. THIS DID NOT AFFECT THE PATIENT AS WE HAVE SIMILAR SCREWDRIVERS ON THE SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982075 ↗
• MalfunctionAug 27, 2018Break

  THE NIAIC REPORT SAID THAT THE TIP OF THE SCREW DRIVER NOTED TO BE BROKEN WHEN THE SCRUB NURSE TRIED TO ATTACH THE LAST SCREW. IT WAS FOUND IN THE PATIENT UNDER X-RAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820644 ↗
• MalfunctionMar 16, 2018Break

  TIP OF SELF HOLDING SCREWDRIVER BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346883 ↗