NA 03.045.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886982292490), received between Jul 11, 2022 and May 28, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED ON MAY 6, 2026 THAT THE RETENTION PIN FOR XL25 SCREWDRIVER IN THE TFNA SYSTEM BROKE MID-SHAFT WHILE INSERTING A 5.0 LOCKING SCREW, THE CASE WAS COMPLETED WITHOUT INCIDENT. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322005 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RETENTION PIN BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094904 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT THREAD OF THE RETENTION PIN IS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775125 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE RETENTION PIN HAS SNAPPED OFF, LIKELY DURING A NAILING CASE. THE BREAKAGE WAS ONLY NOTICED WHEN THE ITEM WAS PREPARED FOR USE IN A SUBSEQUENT CASE. THERE WAS NO PATIENT HARM REPORTED AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416125 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT THE THREAD OF RETENTION PIN XL 25 BROKE INTRAOPERATIVELY. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222119 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE RETENTION PIN BROKE DURING A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184333 ↗
• MalfunctionJan 22, 2026Material Integrity Problem

  IT WAS REPORTED A NEW SET WAS DELIVERED TO CUSTOMER AND THE SCREW DRIVER WITH RETENTION PIN IS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147122 ↗
• MalfunctionDec 24, 2025Break; Break

  DURING AN RFNA PROCEDURE, THREE INSTRUMENTS FAILED WHILE IN USE. THEY WERE NOT MISUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888507 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A TFN PROCEDURE, THE CLAMPING PIECE FOR SCREWS 5.0, DOES NOT SECURE THE SCREW. THE ISSUE WAS SOLVED BY USING ANOTHER SCREWDRIVER. THERE WAS ALSO AN ISSUE DISASSEMBLING THE CONNECTION SCREW THAT ATTACHES THE NAIL TO THE ARM. THERE WAS NO NEED TO REMOVE THE NAIL. FINALLY, THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881082 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THE RETENTION PIN FOR SCREWDRIVER WAS RECEIVED BROKEN BETWEEN THE BODY AND THREADED PART. THERE WAS NO IMPACT TO ANY PROCEDURES OR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878610 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THE THREADED PART AT THE TIP OF THE INSTRUMENT HAS BROKEN OFF. THE BROKEN PART WAS FOUND COMPLETELY AND DID NOT REMAIN IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE REMOVED EASILY FROM PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23769613 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A TNA CASE, WHEN INSERTING ONE OF THE PROXIMAL 5MM XL25 LOCKING SCREWS, INITIALLY THE SCREW WAS CAPTURED ONTO THE SCREWDRIVER USING THE RETENTION PIN. DURING FINAL STAGES OF INSERTING THE SCREW, THE SURGEON NOTED THAT THE SCREWDRIVER SHAFT HAD COME AWAY FROM THE SCREW, DESPITE NOT UNSCREWING THE RETENTION PIN TO RELEASE IT FROM THE SCREW HEAD. WHEN THE SCREWDRIVER WAS REMOVED, IT WAS NOTED THAT THE THREADED END OF THE RETENTION PIN WAS MISSING AND THUS WAS BROKEN. THE SCREW WAS REMOVED, AND THE BROKEN TIP OF THE RETENTION PIN COULD BE SEEN IN THE HEAD OF THE 5MM SCREW. NO ADVERSE PATIENT HARM WAS REPORTED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680462 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089959 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MULTIPLE SCREWDRIVERS WERE NOT SECURING ONTO SCREWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089766 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT THE THREADED PORTION OF THE RETENTION PIN HAVE SNAPPED OF DURING AN OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976454 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL SHAFT FRACTURE WITH THE RETENTION PIN. INTERNAL FIXATION WAS PERFORMED USING TNA (TIBIAL NAIL ADVANCED) FOR A TIBIAL SHAFT FRACTURE. WHEN INSERTING THE END CAP +15MM, THE DRIVER AND THE CORRESPONDING RETENTION PIN WERE USED. DIFFICULTY WAS ENCOUNTERED WHEN INSERTING THE END CAP, AND WHEN THE DRIVER WAS REMOVED, IT WAS FOUND THAT THE END CAP WAS NOT BEING GRIPPED. UPON CHECKING, IT WAS FOUND THAT THE TIP OF THE RETENTION PIN HAD BROKEN OFF AND REMAINED INSIDE THE END CAP. A DIFFERENT LENGTH END CAP +10MM WAS INSERTED USING ANOTHER DRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY FIVE MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828869 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT BOTH INSTRUMENTS BROKE IN THE COURSE OF NORMAL USE DURING SURGERY ON AN UNKNOWN DATE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730612 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THE RETENTION PIN BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22725598 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THE RETENTION PIN BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22725524 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL SHAFT FRACTURE WITH THE RETENTION PIN. WHEN INSERTING THE PROXIMAL SCREW DURING THE SURGERY USING THE TNA, THE SURGEON WAS GRASPING WITH THE RETENTION PIN AND INSERTING THE SCREW, THE TIP OF RETENTION PIN BROKE AND UNABLE TO GRASP ANYMORE. THE SCREW WAS REMOVED ONCE, AND THE RETENTION PIN WAS CONFIRMED TO BE STILL INSIDE THE SCREW HEAD. THE SURGEON DECIDED TO INSERT THE SCREW WITH A SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344495 ↗
• MalfunctionJun 18, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286657 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT THE RETENTION PINS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028541 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE RETENTION PIN IS BROKEN. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21961984 ↗
• MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN USING THE IMPLEMENTS, THE RETENTION PIN FOR SCREWDRIVER WAS DAMAGED IN THE EDGES OF THE THREAD IN ITS TIP. THE TWO BITS PRESENTED AFFECTATIONS - ONE WAS BROKEN AND THE OTHER HAD WEAR IN THE TIP. DUE TO THESE DEVELOPMENTS, THERE WERE NO DISCOMFORT ON THE PART OF THE SURGEON SINCE THE TEAM HAD SEVERAL PIECES AND COULD BE RESOLVED, FINISHING THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621147 ↗
• MalfunctionJan 24, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT HAD BROKEN DURING THE OPERATION AND THE THREADED PART HAD REMAINED IN THE SCREW HEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 21231081 ↗