NA 03.037.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10886982070357), received between Oct 15, 2018 and Sep 30, 2026 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (37 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Slipped; Device-Device Incompatibility

  It was reported on an unknown date that TFNA Scr Insert device lag screws aren't going on to this piece. The ratchets were not holding

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950156 ↗
• MalfunctionSep 30, 2026Material Deformation

  It was reported that the Driving Cap f/Insertion Handle, Multihole Drill Sleeve, Trocar yell, ScrDriver-hex 5 flex cann, Extract-Instr f/TFNA Helical Blade+Scr, ScrDriver short XL25, ScrDriver w/Quick-Coupl hex 12 short XL2, Hand lrg cann w/Quick-Coupl Hex12, ConnecScr f/TFNA Helical Blade+Scr, and ScrDriver Shaft self-holding L165 f/Star were associated with wear-related and deformation issues. The reported failures included stripped or worn threads that did not engage securely, deformed holes that made guide wire passage difficult, a bent trocar that did not fit the cannula properly, dull screwdriver features that did not seat securely or function properly, and a handpiece that no longer clicked into screwdriver shafts. There was no patient involvement. The complaint devices were retained by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945917 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937090 ↗
• MalfunctionSep 24, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885567 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459945 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459943 ↗
• MalfunctionJul 6, 2026Degraded

  IT WAS REPORTED DURING THE LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT AT LOC UMKIRCH, THE FOLLOWING PRODUCT DEVIATION WAS IDENTIFIED: THE COLOR CODING ON INSTRUMENT MISSING THE PRODUCT NOT COMPLAINED BY ANY CUSTOMER. THERE IS NO PATIENT IMPACT, AND NO SURGERY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716688 ↗
• MalfunctionJun 30, 2026Degraded

  IT WAS REPORTED THAT DURING THE LOCAL/INTERNAL INSPECTION IN THE ORTHOKIT LOANER DEPARTMENT IT WAS IDENTIFIED THAT THE COLOR CODING ON INSTRUMENT IS MISSING. THE PRODUCT WAS NOT COMPLAINED BY ANY CUSTOMER. THERE WAS NO PATIENT IMPACT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE SHAFT OF THE TROCAR YELL WAS BENT AND THE COLOR MARKINGS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667139 ↗
• 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 25241476 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED DURING THE PROCEDURE, WHEN THE DOCTOR USED THE REFERENCE TROCAR, IT BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764361 ↗
• 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 24363812 ↗
• 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 24299815 ↗
• 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 24299814 ↗
• 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 24299780 ↗
• 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 24273307 ↗
• 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 24161278 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS NOTICED POSTOPERATIVELY THAT THE TROCAR WAS BENT AND DIDN'T FIT IN THE DRILL SLEEVE ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850511 ↗
• MalfunctionAug 5, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE COLOR CODING GOT LOST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715875 ↗
• 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 22321891 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TORCAR IS NOT FULLY CONNECTING TO JIG. BENDING IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235990 ↗
• 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 21920308 ↗
• 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 21920201 ↗
• 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 21920158 ↗
• 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 21919927 ↗
• 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 21919888 ↗