NA 03.010.500Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982069177), received between Oct 29, 2020 and Mar 20, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Contamination /Decontamination Problem

  IT WAS REPORTED ON AN UNKNOWN DATE WHITE COATING STAINED FROM CSPD EXPIRED SOLVENT. LEFT A WHITE RESIDUE ON THESE INSTRUMENTS, UNABLE TO SCRUB OFF. THERE WAS NO PATIENT CONSEQUENCES .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647739 ↗
• MalfunctionMar 20, 2026Contamination /Decontamination Problem

  IT WAS REPORTED ON AN UNKNOWN DATE WHITE COATING STAINED FROM CSPD EXPIRED SOLVENT. LEFT A WHITE RESIDUE ON THESE INSTRUMENTS, UNABLE TO SCRUB OFF. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647737 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, STERILE PROCESSING DETERMINED THAT ITEMS WERE DAMAGED AND COULD NOT BE PUT BACK IN SETS. A SILICONE HANDLE HAD A KNIFE CUT THROUGH IT. HOLDING SLEEVES WERE MISSING THEIR SPRINGS AND NOT ABLE TO BE USED. SHORT RETENTION PINS HAD THE THREADED TIPS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555371 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496608 ↗
• MalfunctionSep 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT INSERTION HANDLE AND PROTECTION SLEEVE WERE BROKEN. INSIDE OF HANDLE IS STRIPPED AND PROTECTION SLEEVE INSERTION PART IS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036310 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SLEEVES DO NO FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737726 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SLEEVES DO NO FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737676 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SLEEVES DO NOT FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737170 ↗
• MalfunctionJun 13, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS WERE UNABLE TO STERILIZE/ASSEMBLE. THESE ITEMS WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202790 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS BROKEN. THE HANDLE WAS NOT FUNCTIONAL WITH QUICK COUPLING, AND THE HANDLE WAS DISCARDED. NO PATIENT WAS INVOLVED; THE ISSUE WAS DISCOVERED AFTER THE PROCEDURE IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256429 ↗
• MalfunctionSep 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SILICONE QC IS NOT ATTACHING TO TISSUE PROTECTOR. THERE WAS NO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183487 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SPRING BROKE. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163270 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AUG 13, 2024 THE SPRING BROKE. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163261 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AUG 13, 2024, THE SPRING BROKE. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163258 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER SURGERY, THE TWO SCREWS GOT STUCK IN THE COUPLING HANDLE AND CANNOT BE PICKED OUT OR REMOVED. NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034455 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BLUE HANDLE IN THE ANS INSTRUMENTS IS BROKEN. UNKNOWN IF THERE WERE PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19281666 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON FEBRUARY 23 2024. IT WAS REPORTED THAT THE INSTRUMENTS WERE STUCK TOGETHER AND COULD NOT BE PULLED APART. NO PATIENT INVOLVED. THIS OCCURRED PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886134 ↗
• MalfunctionMar 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. PRIOR TO THE PROCEDURE WHEN STAFF DISASSEMBLED THE COUPLING RING HANDLE, STAINS FROM A FOREIGN SUBSTANCE THAT APPEARED TO BE BLOOD WERE FOUND. THE DISCOVERY WAS MADE PRIOR TO STERILIZATION, SO THERE WAS NO IMPACT TO THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875365 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 3, 2024, THE COUPLING CAP WAS REMOVED FROM THE ITEM AND COULD NOT BE PUT BACK ON. THE ITEM WAS DISPOSED OF. THERE WAS NO PATIENT INVOLVEMENT OR SURGICAL DELAY. THE ISSUE OCCURRED POSTOPERATIVELY. THIS REPORT INVOLVES ONE SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542762 ↗
• MalfunctionAug 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) OF 2023, IF WAS FOUND THAT THE TIP OF THE HANDLE IN QUESTION COULD NO LONGER BE DISASSEMBLED/ASSEMBLED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471253 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWDRIVER HANDLE IN QUESTION WAS FOUND TO BE NO LONGER FUNCTIONING. OTHER ATTACHMENTS COULD NOT BE CONNECTED TO THE HANDLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583880 ↗
• MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE RFNA NAILS HAD SCREW BACKOUT POST OP, THE DRIVE CAP BROKE INSIDE TFNA INSERTION HANDLES, AND THE SLEEVE WAS COLD WELDED IN THE BLUE HANDLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919083 ↗
• MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE RFNA NAILS HAD SCREW BACKOUT POST OP, THE DRIVE CAP BROKE INSIDE TFNA INSERTION HANDLES, AND THE SLEEVE WAS COLD WELDED IN THE BLUE HANDLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919036 ↗
• MalfunctionNov 3, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COUPLING WAS BROKEN ON THE HANDPIECE. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721359 ↗
• MalfunctionJul 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SILICON HANDLE WITH QUICK COUPLING WHICH IS A TISSUE PROTECTOR HANDLE AND LOOKS LIKE ONE OF THEM NUB AND ADMITTING FROM THE HANDLE SO THE PIECE JUST FALL OUT OF IT AND IT DOESN¿T ALLOW TO BE CLICK AND HOLD THE TISSUE PROTECTOR. ALSO THE UNIVERSAL CHUCK 2.5MM GUIDEWIRE WAS TOCK IN THE T -HANDLE AND T-HANDLE WILL NOT RELEASE THE 2.5 MM GUIDEWIRE. THE ISSUE WAS DISCOVERED POSTOP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950073 ↗