NA 03.043.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982297266), received between Oct 5, 2022 and Apr 3, 2026 — classified as 1 injury, 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Material Twisted/Bent

  IT WAS REPORTED ON UNKNOWN DATE THAT DURING THE CASE THE T HANDLE SEEMED TO BE STRIPPING IN THE EVENT OF THE NAIL REMOVAL FROM THE INSERTION HANDLE. SURGERY DELAYED DUE TO THE REPORTED EVENT . T HANDLE WAS DISCARDED DUE TO THE EVENT OCCURRED. SURGERY SUCCESSFULLY COMPLETED. NO WERE FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777822 ↗
• MalfunctionMar 24, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY SPECIFIC ALLEGATION AGAINST THE UNK - NAILS: TIBIAL? NO. WERE THERE ANY OTHER DEVICES INVOLVED WITH THIS CASE? IF YES PLEASE PROVIDE THE PRODUCT CODE, LOT NUMBER AND ALLEGATION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673711 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT, THE SURGEON WAS INSERTING A TIBIA NAIL ADVANCED AND THE SURGEON EXPERIENCED THE FOLLOWING ISSUES: THE AIMING ARM, RADIOLUCENT WAS WORN DOWN AND TROCARS HAVE TOO MUCH MOVEMENT INSIDE THE DESIGNATED HOLES. THE TROCARS DO NOT FIT SNUG INTO THE AIMING ARM ANYMORE. THE INSERTION HANDLE LONG, RADIOLUCENT WAS GETTING STUCK ON THE NAIL WHEN TRYING TO SEPARATE THE TWO PIECES. THIS HAS BEEN AN ISSUE FOR THE SECOND CASE IN A ROW. THE CONNECTION SCREW NEEDS TO BE REPLACED WITH THE INSERTION HANDLE BECAUSE THE NAIL KEEPS GETTING STUCK WHEN TRYING TO DISCONNECT THE NAIL FROM THE INSERTION HANDLE. THE 8MM HEXAGON T-HANDLE SCREWDRIVER WAS POSSIBLY STRIPPED AND NOT ENGAGING IN CONNECTION SCREW. THE LONG REAM ROD PUSHER (BLUE BALL HANDLE) HAS A WEEK SPOT IN SHAFT, ABOUT TO SNAP IN HALF WHEN PRESSURE IS PUT ON SHAFT WHILE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084340 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE S1 HIT ON TNA WITH NEW CONNECTING SCREWS, IT WAS ADVISED TO REPLACE ALL INSERTION HANDLES, AIMING ARMS, AND T HANDLE ACORNS. IT COULD NOT BE FIGURED THE CAUSE OF S1 HITTING. ALL ITEMS NEEDS TO BE REPLACED. INSERTS ARE FADED WITH WHITE RESIDUE FROM SPRAY. CSPD WON¿T STERILIZE SET. THERE WAS NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117344 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE S1 HIT ON TNA WITH NEW CONNECTING SCREWS, IT WAS ADVISED TO REPLACE ALL INSERTION HANDLES, AIMING ARMS, AND T HANDLE ACORNS. IT COULD NOT BE FIGURED THE CAUSE OF S1 HITTING. ALL ITEMS NEEDS TO BE REPLACED. INSERTS ARE FADED WITH WHITE RESIDUE FROM SPRAY. CSPD WON¿T STERILIZE SET. THERE WAS NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117157 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE S1 HIT ON TNA WITH NEW CONNECTING SCREWS, IT WAS ADVISED TO REPLACE ALL INSERTION HANDLES, AIMING ARMS, AND T HANDLE ACORNS. IT COULD NOT BE FIGURED THE CAUSE OF S1 HITTING. ALL ITEMS NEEDS TO BE REPLACED. INSERTS ARE FADED WITH WHITE RESIDUE FROM SPRAY. CSPD WON¿T STERILIZE SET. THERE WAS NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116984 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE S1 HIT ON TNA WITH NEW CONNECTING SCREWS, AND IT WAS ADVISED TO REPLACE ALL INSERTION HANDLES, AIMING ARMS, AND T HANDLE ACORNS. THE CAUSE OF S1 HITTING COULD NOT BE DETERMINED. INSERTS ARE FADED WITH WHITE RESIDUE FROM SPRAY. CSPD WOULD NOT STERILIZE THE SET. THERE WAS NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112685 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE S1 HIT ON TNA WITH NEW CONNECTING SCREWS, AND IT WAS ADVISED TO REPLACE ALL INSERTION HANDLES, AIMING ARMS, AND T HANDLE ACORNS. THE CAUSE OF S1 HITTING COULD NOT BE DETERMINED. INSERTS ARE FADED WITH WHITE RESIDUE FROM SPRAY. CSPD WOULD NOT STERILIZE THE SET. THERE WAS NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112558 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439791 ↗
• MalfunctionDec 5, 2022Material Twisted/Bent; Material Twisted/Bent

  NO OTHER MEDICAL INTERVENTION WAS REQUIRED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920886 ↗
• MalfunctionOct 5, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, AN ISSUE OCCURRED DURING A TIBIAL NAILING PROCEDURE WHEREIN THE DRILL BIT HIT STATIC ONE AFTER COMPRESSION MODE WAS USED. WHILE FINISHING THE PROCEDURE AND TAKING OFF THE INSERTION HANDLE, THE T-HANDLE CANNULATED DRIVER WAS STRIPPED. A SOLID T-HANDLE WAS OPENED AND IT DID NOT GET IT OFF EITHER. A SECOND T-HANDLE WAS OPENED AND THE SURGEON WAS FINALLY ABLE TO GET THE INSERTION HANDLE OFF AFTER RAISING THE LEG. THERE WAS A FIVE-MINUTE SURGICAL DELAY AS A RESULT OF THIS EVENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SCREWDRIVER- W/ T-HANDLE W/ SPHERICAL HEAD/ HEX 8MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544339 ↗