NA 359.219Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 10886982197214), received between Dec 27, 2016 and Aug 28, 2026 — classified as 4 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Break” (157 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 25 most recent of 232 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50496092 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED ON 6TH MAY, 2026 THAT SPD NOTIFIED THE REPORTER OF 2 INSTRUMENTS THAT WERE BROKEN AND NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292731 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE, WHILE MALLETING THE INSERTER, IT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905436 ↗
• MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE IS NOT TIGHTENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533757 ↗
• MalfunctionOct 17, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT IT WAS DISCOVERED THAT THE BLUE HANDLE WAS CRACKED AND WOULD NOT ALLOW THE T HANDLE TO TIGHTEN DOWN CORRECTLY AFTER DECONTAMINATION PROCESS WAS DONE AND INSTRUMENT WAS BEING PUT BACK INTO THE SET. IT CAN BE TIGHTENED DOWN WITH EXTRA FORCE AND WILL WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328561 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE HAS A SNAP THAT NO LONGER WORKS. THE ISSUE OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885214 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Material Integrity Problem; Mechanical Jam; Device-Device Incompatibility; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT THE TENS INSERTER AND DRIVING CAP BECAME STUCK. BOTH THE INSERTER AND DRIVING CAP WERE DAMAGED. THERE LOOKS LIKE THERE IS SOME DAMAGE TO THE PROXIMAL THREADS NOT ALLOWING THE IMPACTOR TO FULLY ENGAGE. THEY HAVE ORDERED A NEW DRIVING CAP HOWEVER IT STILL WILL NOT THREAD INTO THE INSERTER. HOSPITAL REQUIRE A NEW TENS INSERTER. NO PATIENT INVOLVEMENT, THE TWO INSTRUMENTS BECAME STUCK WHEN TRYING TO DISASSEMBLE THEM AT THE END OF THE CASE. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744906 ↗
• MalfunctionJul 17, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DEVICES WERE FOUND TO HAVE MANY DENTS, CHIPS, AND SCORING. THERE WAS NO OPERATION AND PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532861 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE END OF THE INSERTER FOR THE TITANIUM ELASTIC NAIL OR THE PART WHERE THE NAIL ATTACHES TO THE INSERTER NO LONGER FUNCTIONS. THE ISSUE WAS IDENTIFIED PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375139 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308873 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE BLUE HANDLE IS BANGED UP AND CHIPPED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298969 ↗
• MalfunctionMay 30, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT BLUE T HANDLE CHUCK WOULD NOT TIGHTEN OR LOOSEN; IT SOUNDED LIKE SOMETHING WAS LOOSE ON THE INSIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113682 ↗
• MalfunctionMay 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T-HANDLE INSERTER WAS FOUND TO NO LONGER SPIN DOWN TO CAPTURE THE ELASTIC NAIL. THIS WAS FOUND BY THE STERILE PROCESSING DEPARTMENT (SPD); THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029844 ↗
• MalfunctionApr 29, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON APRIL 3, 2025, WHILE GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS AND SETS THAT WERE DAMAGED AND IN NEED OF BEING REPLACED. THE DEPTH GAUGE WAS BENT ALMOST TO THE POINT OF BREAKING AND NEEDS TO BE REPLACED. THERE WAS A TITANIUM, ELASTIC NAIL AND THE PLASTIC PIECE ON IT IS BROKEN AND CRACKED AND WAS IN NEED OF BEING REPLACED. THERE WAS A TITANIUM, ELASTIC NAIL GRAPHIC CASE, AND THIS GRAPHIC CASE HAS A PLASTIC COATING ON IT, AND THAT PLASTIC COATING HAS BEGAN TO FLAKE OFF. THERE WERE TWO SETS THAT HAD THIS DAMAGE TO THEM, AND BOTH SETS WERE DISCARDED BY THE FACILITY AND THEY ARE UNABLE TO BE RETURNED. THE DAMAGE TO THESE INSTRUMENTS AND GRAPHIC CASES WAS POSTOPERATIVELY AFTER GOING THROUGH THE DECONTAMINATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ACTION NEEDED DURING ANY SURGICAL CASE NO OTHER SETS WERE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925168 ↗
• MalfunctionMar 17, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. ALSO THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619012 ↗
• MalfunctionDec 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE INSERTER WOULD NOT TIGHTEN PROPERLY TO HOLD ELASTIC NAIL AND THE PIN THAT HELD THE THREADS OF THE CUTTER, THE STOP NUT AND CUTTING SLEEVE WERE WORN DOWN AND CROSS-THREADED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029661 ↗
• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A TENS NAIL INSERTER WAS NOT WORKING. DURING THE CASE, IT WASN'T GRIPPING. THE HOSPITAL HAD TO OPEN ANOTHER SET TO GET SOMETHING TO USE AS AN INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 20506592 ↗
• MalfunctionSep 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN INSERTER WAS RECEIVED AS A BLIND UNIT. VISUAL INSPECTION PERFORMED ON (B)(6) 2024 DETERMINED THAT THE DEVICE WAS BROKEN FROM THE HANDLE. THIS REPORT IS FOR AN INSERTER FOR TI ELASTIC NAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334664 ↗
• MalfunctionJun 28, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. NUMEROUS STAINS WERE ADHERING TO THE RUBBER PART OF SEVERAL PRODUCTS. THE INSTRUMENTATION NURSE, AT THE DISCRETION OF THE PRIMARY SURGEON, WIPED OFF THE STAINS WITH A TOWEL, AND THE SAID PRODUCTS WERE USED DURING THE SURGERY. IT WAS CONFIRMED THAT THE PRODUCTS WERE ALSO MORE WATER-REPELLENT THAN USUAL DURING POST-OPERATIVE CLEANING. THIS REPORT IS FOR ONE INSERTER F/TEN THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19637140 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT T-HANDLE IS BROKEN. THERE IS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620093 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLASTIC CASING HAD BROKEN. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. THIS REPORT INVOLVES ONE INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352870 ↗
• MalfunctionMay 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE DEVICE HAS A MECHANISM THAT DOES NOT SEEM TO ALLOW THE T-HANDLE TO TIGHTEN OR LOOSEN. ENTIRE HANDLE HAD TO BE TAKEN APART. IT WAS UNKNOWN, IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE INSERTER FOR TI ELASTIC NAILS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330265 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT ON 3/25/2024 NOTIFIED BY SPD OF ITEMS IN TRAY THAT WERE BROKEN AND NO LONG ABLE TO BE USED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) INSERTER FOR TI ELASTIC NAILS THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060861 ↗
• MalfunctionFeb 27, 2024Break; Break

  IT WAS REPORTED THAT THE EVENT OCCURRED POST-OPERATIVELY AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18787285 ↗
• MalfunctionJan 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE, AFTER HAMMERING IN AN ELASTIC NAIL THESE METAL PRONGS CAME OUT OF THE HANDLE. THERE WERE NO INJURIES. ANOTHER HANDLE WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) INSERTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516432 ↗