NA 03.037.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10886982070340), received between Jan 13, 2017 and Sep 29, 2026 — classified as 2 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (72 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  It was reported that the stepped ream for TFNA helical blade and screw was used during insertion of a TFNA nail. During preparation for the proximal locking portion of the case, the 10 mm cannulated drill bit was used without incident, after which the 6/9 tapered drill bit fractured at the tip in the femoral neck and was described as crumbling like dust after brief contact in the patient. It was also reported that substantial torque was applied to the insertion handle and aiming arm jig to achieve trajectory and reduction, and that the 3.2 guide wire bent during insertion of the lag screw head element. Additional impacted products were the insert handle, 3.2 mm wire guide sleeve, lock insert for aim arm, 3.2 mm trocar, blade/screw guide sleeve, and 125 degree aiming arm. Fragments were generated, retained in the patient, and additional intervention was required to remove the retained fragments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936956 ↗
• MalfunctionSep 24, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885556 ↗
• MalfunctionSep 2, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571773 ↗
• MalfunctionSep 2, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571698 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459752 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459739 ↗
• 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 24363775 ↗
• MalfunctionFeb 9, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299819 ↗
• MalfunctionFeb 9, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299813 ↗
• MalfunctionFeb 9, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT TFNA INSERTION HANDLES AND GUIDES WERE NOT POSITIONING THE GUIDE WIRES CORRECTLY. T HANDLES FOR LAG SCREWS ARE DEFORMED AND DIFFICULT TO INSERT THE LAG SCREW ON FOR INSERTION. DHS REAMER IS DAMAGED AND NOT SAFE FOR USE. REAMER ADAPTERS ARE STARTING TO BECOME JAMMED ONTO REAMER. RADIOGRAPHIC RULER BENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299796 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDE WIRE MISSED THE NAIL HOLE FOR HELICAL BLADE. SURGERY WAS DELAYED FOR FORTY (40) MINUTES DUE TO THE REPORTED EVENT. THE NAIL WAS REMOVED AND REINSERTED USING SECOND SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273306 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A TFNA, THE HELICAL BLADE OR TRIPLE TROCAR HAS BEEN CATCHING. WE WEREN¿T ABLE TO GET THE HELICAL BLADE INSERTED/TROCAR OUT OF THE AIMING ARM/COMPRESSION NUT. NOT SURE WHICH PART WAS THE ISSUE. NO PATIENT HARM. SURGICAL DELAY OF 5-10 MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160488 ↗
• MalfunctionJan 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE 3.2 WIRE GUIDE SLEEVE WAS GETTING STUCK/DIFFICULT TO PULL OUT OF THE BLADE/SCREW SLEEVE. THERE WAS A 3 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995986 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Device-Device Incompatibility; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286280 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Device-Device Incompatibility; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285591 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Device-Device Incompatibility; Nonstandard Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285588 ↗
• MalfunctionSep 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING DOING A STAFF IN SERVICE FOR TFNA. THE BLADE\SCREW GUIDE WOULD NOT SLIDE INTO THE AIMING ARM. NOT SURE IF SOMETHING IS BENT ON AIMING ARM OR BLADE\SCREW GUIDE. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043097 ↗
• MalfunctionJul 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE TROCAR IS NOT FULLY CONNECTING TO JIG; BENDING IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578010 ↗
• MalfunctionJul 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE GUIDE WIRE SLEEVE WAS DAMAGED DURING CLEANING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418825 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE TFNA AIMING ARM AND ASSOCIATED PIECES GET JAMMED AND STUCK BEFORE FULL INSERTION IS ACHIEVED; IT WAS NOTED ABNORMALLY HIGH RESISTANCE IS EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321866 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920134 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919856 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919855 ↗
• MalfunctionMar 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON FEBRUARY 24, 2025, GUIDE SLEEVE WAS BENT, AIMING ARM WAS BENT, THE NUT WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632486 ↗
• MalfunctionMar 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PRODUCT WAS INSPECTED DURING PRE OP SETUP AND FOUND TO BE BENT AND UNABLE TO BE USED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619614 ↗