NA 03.037.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 346 adverse event reports that list this exact device (DI 10886982070333), received between Dec 21, 2016 and Sep 29, 2026 — classified as 9 injuries, 337 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (239 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 346 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937137 ↗
• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933084 ↗
• MalfunctionSep 25, 2026Device-Device Incompatibility; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902420 ↗
• MalfunctionSep 24, 2026Material Deformation

  It was reported that during the proximal locking portion of the TFNA case, Surgeon inserted a 10mm cannulated tapered drill bit and noticed some ¿chatter¿. He then inserted the 6/9 drill bit and it made more pronounced chatter. Upon pulling the 6/9 drill bit out, they took x rays and noticed fragments of the tip of the drill bit in the femoral neck. They also inspected the 10mm cannulated tapered drill bit and noticed that the tip of the drill bit was broken as well with fragments in the patient¿s femoral neck. Attempts were made to remove the fragments, but some remained in the patient. It was further reported that the 3.2MM WIRE GUIDE SLEEVE, BLADE/SCREW GUIDE SLEEVE or 3.2MM TROCAR may be bent and was causing issue. New drill bits and proximal locking triple sleeves were opened, and the procedure was completed with a reported 20-minute delay. The case was completed without incident. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885561 ↗
• MalfunctionSep 2, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571808 ↗
• MalfunctionSep 2, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571669 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459692 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459688 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT THE GUIDE SLEEVE WILL NO LONGER ENGAGE ALL THE WAY DOWN AND THERE WERE SOME METAL SHAVINGS ON THIS THAT ARE BELIEVED TO BE FROM THE INNER SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373936 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT MATERIALS WERE BENT AND UNABLE TO CORRECTLY SLIDE INTO THE POSITION THEY NEED TO BE IN TO CORRECTLY ADHERE TO ONE ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241708 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SLEEVE IS NOT ALIGNED ANYMORE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215532 ↗
• MalfunctionMay 15, 2026Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED IT WAS HARD TO SCREW IN SLEEVE FOR TFNA BLADE. THE THREADS SEEM DAMAGED PROXIMALLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183112 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT THREADS OF THE DEVICE ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071036 ↗
• MalfunctionApr 22, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE OUTER TROCAR SLEEVE IS BENT AND WILL NOT COMPLETELY GO THROUGH THE AIMING ARM. AS WELL AS THE INNER TROCAR SLEEVE WILL NOT FIT DOWN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957889 ↗
• MalfunctionApr 21, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE THREADS OF THE SCREW INSERTER WAS DAMAGED/CHIPPED. THE GUIDE SLEEVE WAS NOT PASSING THROUGH THE SLEEVE SMOOTHLY. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937583 ↗
• MalfunctionApr 14, 2026Break; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT TFNA FEM NAIL Ø12 LE 125° L235 TIMO15 AND GUIDE SLEEVE YELL WERE INVOLVED IN AN INTRA-OPERATIVE EVENT. DURING A TFNA CASE, AFTER USE OF THE LATERAL CORTEX OPENING DRILL BIT AND TAPERED STEPPED REAMER, METAL SHAVINGS WERE OBSERVED IN THE PROXIMAL FEMUR AND AROUND THE DRILL BIT, AND THE GUIDEWIRE WAS NOTED TO BE SLIGHTLY BENT. THE SURGEON ELECTED TO LEAVE THE METAL SHAVINGS AND NAIL IN SITU AND REQUESTED THE DRILL BIT AND GUIDE SLEEVE BE SENT FOR TESTING TO DETERMINE THE SOURCE OF THE SHAVINGS. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875275 ↗
• MalfunctionMar 13, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING PRE-OPERATIVE INSPECTION IT WAS IDENTIFIED THAT THE BUTTRESS/COMPRESSION-NUT IS STUCK ON THE SLEEVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590330 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429857 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429851 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENTS ARE ALL STRIPPED AND NO LONGER FIT TOGETHER IN ORDER TO ACHIEVE COMPRESSION OF THE NAIL/FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429779 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026 UPON DISENGAGING TFNA LAG SCREW DRILL/INSERT SLEEVE, THE OUTER SLEEVE AND BUTTRESS WHEEL WOULD NOT DISENGAGE. SURGEON AND SCRUB TECH USED A MALLET TO RELEASE IT AND CAUSED THE BUTTRESS WHEEL TO CROSS THREAD WITH THE OUTER SLEEVE. SURGERY WAS DELAYED FOR 5 MINUTES DUE TO THE REPORTED EVENT. MALLETED SLEEVE AND WHEEL OUT, PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369765 ↗
• MalfunctionFeb 17, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT INSERT-HANDLE, AIM-ARM 125° F/STAT DIST LOCK, BLADE/SCREW GUIDE SLEEVE, DRILLSL YELL, TROCAR YELL, BUTTRESS/COMPR-NUT, SCREW INSERTER, CONNECSCR F/TFNA HELICAL BLADE+SCR, DHS® TRIPLE REAMER, COMPLETE, WITH LONG REAMER, AND FLEX SFT CONNECTOR FOR USE JACOBS CHUCK WERE ASSOCIATED WITH ISSUES INCLUDING IMPROPER POSITIONING OF GUIDE WIRES BY INSERTION HANDLES AND GUIDES, DEFORMATION OF T HANDLES FOR LAG SCREWS MAKING INSERTION DIFFICULT, DAMAGE TO THE DHS REAMER RENDERING IT UNSAFE FOR USE, REAMER ADAPTERS BECOMING JAMMED, AND A BENT RADIOGRAPHIC RULER. THE EVENT OCCURRED PRE-OPERATIVELY AND DID NOT INVOLVE THE PATIENT, NOR DID IT OCCUR DURING STERILE PROCESSING OR FIELD INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363752 ↗
• MalfunctionFeb 6, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280553 ↗
• MalfunctionFeb 6, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280548 ↗
• MalfunctionFeb 6, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. AIMING ARMS WERE STARTING TO BECOME JAMMED AND WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280529 ↗