NA 03.010.072Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10886982067449), received between Oct 2, 2018 and Sep 23, 2026 — classified as 1 injury, 132 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (82 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation

  It was reported that the TFNA depth gauges bent until the point that they no longer pass through the sleeves properly. They cannot measure screw length accurately. There was no patient harm and no surgical delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869411 ↗
• MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation

  It was reported that the TFNA depth gauges bent until the point that they no longer pass through the sleeves properly. They cannot measure screw length accurately. There was no patient harm and no surgical delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869401 ↗
• MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation

  It was reported that the TFNA depth gauges bent until the point that they no longer pass through the sleeves properly. They cannot measure screw length accurately. There was no patient harm and no surgical delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869399 ↗
• MalfunctionSep 22, 2026Material Deformation

  It was reported that during routine medical device reprocessing, staff indicated that the depth gauge is no longer in proper working condition. The tip of the depth gauge was found to be bent and damaged. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856426 ↗
• MalfunctionAug 12, 2026Material Deformation; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225658 ↗
• MalfunctionMar 26, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698759 ↗
• MalfunctionMar 20, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653138 ↗
• MalfunctionMar 20, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652341 ↗
• MalfunctionMar 19, 2026Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT SEVERAL DEPTH GAGES ARE BENT/NO LONGER ACCURATE. VA GUIDES WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. SCREWDRIVER SHAFTS WORN DOWN. USF HANDLES ARE SPINNING ON SCREW WHEN SURGEON IS TIGHTENING DOWN SCREWS. TROCARS ARE BENT/UNSTABLE. NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642671 ↗
• MalfunctionMar 11, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE OPENED BUT NOT USED DUE TO IT BEING TOO BIG FOR THE PATIENT. ENDED UP USING A 2.7 LCP PLATE INSTEAD. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568881 ↗
• MalfunctionFeb 4, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS IMPACTING DRIVING CAP IN THE PRESCRIBED FASHION, THE INSTRUMENT BROKE IN HALF IN THE MIDDLE OF THE SPAN OF THREADS WHICH THREAD INTO THE INSERTION HANDLE. BOTH PIECES WERE RETRIEVED AND THE INSTRUMENT WAS IMMEDIATELY DEEMED TO BE NO LONGER FUNCTIONAL. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE CARBON FIBRE UNDERSIDE OF THE ARCH-SHAPE OF INSERT-HANDLE HYBRID HAD BECOME ROUGH AND SHARP AND NO LONGER SMOOTH, AS IT WAS ONCE. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THIN, DELICATE METAL TIPS OF TWO (2) DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ HAD BECOME BENT AND DAMAGED. THESE TWO ITEMS WERE ASSESSED AS BEING NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263003 ↗
• MalfunctionFeb 4, 2026Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS IMPACTING DRIVING CAP IN THE PRESCRIBED FASHION, THE INSTRUMENT BROKE IN HALF IN THE MIDDLE OF THE SPAN OF THREADS WHICH THREAD INTO THE INSERTION HANDLE. BOTH PIECES WERE RETRIEVED AND THE INSTRUMENT WAS IMMEDIATELY DEEMED TO BE NO LONGER FUNCTIONAL. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE CARBON FIBRE UNDERSIDE OF THE ARCH-SHAPE OF INSERT-HANDLE HYBRID HAD BECOME ROUGH AND SHARP AND NO LONGER SMOOTH, AS IT WAS ONCE. IN ADDITION, DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THIN, DELICATE METAL TIPS OF TWO (2) DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/ HAD BECOME BENT AND DAMAGED. THESE TWO ITEMS WERE ASSESSED AS BEING NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262960 ↗
• MalfunctionNov 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT SCREW DRIVER BROKE DURING SCREW IMPLANTATION. DEPTH GAUGE IS STICKY AND IS VERY DIFFICULT TO USE. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587272 ↗
• MalfunctionJul 3, 2025Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP). ALL ITEMS WERE NOTICED PRE-OP BEFORE A PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394529 ↗
• MalfunctionJul 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT MULTIPLE DEPTH GAGES WERE FOUND TO BE INCOMPLETE AND NEEDED TO BE REPLACED. DEPTH GAGES FOR TFNA WERE BENT AND UNSAFE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369931 ↗
• MalfunctionJul 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT MULTIPLE DEPTH GAGES WERE FOUND TO BE INCOMPLETE AND NEEDED TO BE REPLACED. DEPTH GAGES FOR TFNA WERE BENT AND UNSAFE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369930 ↗
• MalfunctionJul 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT MULTIPLE DEPTH GAGES WERE FOUND TO BE INCOMPLETE AND NEEDED TO BE REPLACED. DEPTH GAGES FOR TFNA WERE BENT AND UNSAFE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369929 ↗
• MalfunctionJul 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT MULTIPLE DEPTH GAGES WERE FOUND TO BE INCOMPLETE AND NEEDED TO BE REPLACED. DEPTH GAGES FOR TFNA WERE BENT AND UNSAFE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369928 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROUTINE MEDICAL DEVICE REPROCESSING, THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT COMPLAINED ITEMS (03.010.072 QUANTITY: 2) WERE BENT AT THE TIP, AND AS A RESULT WERE DEEMED TO BE NO LONGER FUNCTIONAL. THESE ITEMS WERE SUBSEQUENTLY DISCARDED (REDACTED). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037225 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROUTINE MEDICAL DEVICE REPROCESSING, THE MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT COMPLAINED ITEMS (03.010.072 QUANTITY: 2) WERE BENT AT THE TIP, AND AS A RESULT WERE DEEMED TO BE NO LONGER FUNCTIONAL. THESE ITEMS WERE SUBSEQUENTLY DISCARDED (REDACTED). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037223 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, POST OP INSPECTION REVEALED WARPED SCREWDRIVERS AND BENT DEPTH GAUGES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971717 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, POST OP INSPECTION REVEALED WARPED SCREWDRIVERS AND BENT DEPTH GAUGES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971716 ↗
• MalfunctionApr 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED WARPED SCREWDRIVERS AND BENT DEPTH GAUGES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937484 ↗
• MalfunctionMar 18, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DEPTH GAUGE TIP WAS BROKEN/BENT. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633335 ↗
• MalfunctionJan 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE DEPTH GAUGE TIP WAS DAMAGED, TWISTED AND BENT. THE PROCEDURE WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME BUT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105095 ↗