NA 319.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10886982189950), received between Apr 10, 2017 and Sep 29, 2026 — classified as 113 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (58 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935059 ↗
• MalfunctionSep 15, 2026Incorrect Measurement; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774150 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 4NM TORQUE LIMITERS NO LONGER LATCH ONTO THE AO REAMING COUPLER. THE CABLE CUTTER HAS AN INTERNAL SCREW LOOSE. THE LONG PELVIC 2.5 DRIVERS WERE ROUNDED OFF AT THE TIPS. THE SMALL FRAG DEPTH GAUGES HAVE BROKEN TIPS. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125996 ↗
• MalfunctionApr 14, 2026Material Deformation

  IT WAS REPORTED THAT THE RATCHETING MECHANISM WAS FAULTY; DEPTH GAUGE TIP BENT OFF. THERE WAS NO PATIENT STATUS/OUTCOME/CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876738 ↗
• 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 24651900 ↗
• 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 24651899 ↗
• 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 24651895 ↗
• 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 24642654 ↗
• MalfunctionNov 14, 2025Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF NOTICED THAT THE TIP OF THIS DEPTH GAUGE WAS SEVERELY BENT AND DEFORMED. THE TIP WAS NO LONGER HOOKED TO CATCH THE FAR CORTEX AND THIS DEVICE CANNOT BE USED TO GIVE AN ACCURATE MEASUREMENT ANYMORE. NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555227 ↗
• MalfunctionAug 18, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS VERY STICKY AND GOT STUCK. THIS WAS DISCOVERED DURING POST OP INSPECTION. THERE WERE NO PATIENT CONSEQUENCES AS THERE WAS NO PATIENT INVOLVEMENT OR DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827306 ↗
• MalfunctionJul 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT MULTIPLE DEPTH GAUGES 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 22381474 ↗
• 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 22369940 ↗
• 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 22369936 ↗
• 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 22369934 ↗
• 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 22369932 ↗
• MalfunctionApr 28, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DEPTH GAUGE WAS BENT AND NOT FUNCTIONING PROPERLY. IT WAS DISCOVERED DURING POST OP INSPECTION. THERE WAS NO DELAY IN SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921720 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269196 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 6 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038498 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032976 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032364 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031606 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031476 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS IN STERILE PROCESSING DEPARTMENT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031119 ↗
• MalfunctionJul 1, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SURGEON REPORTED THAT THE DEPTH GAUGE IS NOT MEASURING ACCURATELY. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE TIP OF THE DEVICE WAS SLIGHTLY BENT AND WELD BETWEEN SLIDER AND NEEDLE HAD TINY HOLES HOLDING DEBRIS. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645072 ↗
• MalfunctionApr 24, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOOK OF THE DEPTH GAUGE HAD WORN DOWN SIGNIFICANTLY, SO IT' DIDN'T CATCH ON THE BONE WHEN TRYING TO MEASURE FOR SCREW LENGTH. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177112 ↗