NA 319.09Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10886982189998), received between Jan 4, 2017 and Sep 11, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (27 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736198 ↗
• MalfunctionSep 9, 2026Material Deformation

  Patient problems: Insufficient Information

  MAUDE report 50697168 ↗
• MalfunctionJan 20, 2026Corroded

  IT WAS REPORTED THAT WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT THERE WERE SEVERAL INSTRUMENTS THAT WERE EITHER DAMAGED OR HAD ISSUES AND WERE IN NEED OF REPLACEMENT. THE INSTRUMENTS THAT WERE DAMAGED, THEY WERE NOT SURE WHEN THE DAMAGE OCCURRED. SOME OF THE INSTRUMENTS THAT HAD ISSUES HAVE THINGS LIKE RUST IN THE CANNULATION AREAS AND OR THE GRAPHICS CASE WAS BENT BEYOND REPAIR AND/OR WAS FLAKING OFF THE COATING ON THE CASE. THERE WAS NO PATIENT INVOLVEMENT FOR ANY OF THESE ITEMS. 1. PRODUCT # 03.043.028, LOT # 22234101, QUANTITY 1. THIS ITEM IS AN IMPACT FOR THE ANS SYSTEM IN THE PIN THAT IS WELDED HAS COME APART, SO THE PIN IS FLOATING FREE. 2. PRODUCT # 319.09, LOT # 8774P99, QUANTITY 1. THIS ITEM IS A DEPTH GAUGE, AND THERE IS RUST ON PART OF THE DEPTH GAUGE THEY WILL NOT COME OFF. 3. PRODUCT # 03.010.495, LOT # PE05189, QUANTITY 1. THIS ITEM IS A REDUCTION TOOL AND IS CANNULATED WITH RUST ON THE INSIDE OF THE CANNULATION. 4. PRODUCT # 60.527.015, LOT # UNKNOWN, QUANTITY 1. THIS ITEM IS A SCREW RACK AND IS BENT WITH THE LID, UNABLE TO BE LOCKED AND WAS DISPOSED OUT BY THE FACILITY. 5. PRODUCT # 60.333.200, LOT # UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122501 ↗
• MalfunctionSep 3, 2025Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE DEPTH GAUGE WAS BENT AND WILL NOT PROVIDE ACCURATE MEASUREMENTS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954901 ↗
• MalfunctionSep 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE IS BENT. IT IS UNKNOWN IF THE EVENT OCCUR DURING STERILE PROCESSING. IT WAS FROM LOANER SET 3.5MM VA LCP PROXIMAL TIBIAL IMPLANT AND INSTRUMENT SET. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177424 ↗
• MalfunctionMay 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT¿S WORKING END WAS BENT ON 14-MAY-2024. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS NOTED POSTOPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353891 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720467 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720466 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720462 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720461 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720455 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DEPTH GAUGES WERE FOUND DURING STERILE PROCESSING WITH THEIR TIPS BROKEN OFF. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720454 ↗
• MalfunctionFeb 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DEPTH GAUGE BENT. THERE WAS NO PATIENT INVOLVEMENT. EVENT WAS DETECTED PRE-OPERATIVELY. THIS REPORT IS FOR ONE DEPTH GAUGE FOR SMALL SCREWS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660407 ↗
• MalfunctionDec 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE STEM OF THE DEPTH GAUGE WAS BENT AND WOULD NOT MEASURE CORRECTLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278510 ↗
• MalfunctionSep 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE TURNING OVER SETS, I NOTICED TWO DEPTH GAUGES HAD ISSUES. THE 3.5 DEPTH GAUGE HAD ISSUES WITH THE NUT SCREWING ON ALL THE WAY AND THE 1.3/1.5 DEPTH GAUGE WAS VERY ROUGH WHILE SLIDING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE DEPTH GAUGE FOR SMALL SCREWS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765064 ↗
• MalfunctionJul 31, 2023Material Deformation; Material Deformation

  IT WAS ALSO REPORTED THAT THE SURGEON COMPLAINED ABOUT THE FIT OF THE MEDIAL PROXIMAL TIBIA PLATE. THE SURGEON ENDED UP ADJUSTING THE PLATE SLIGHTLY, AND PUT SCREWS IN TO MAKE THE PLATE FIT SLIGHTLY BETTER. HOWEVER, AFTER THE SURGERY IT WAS ALSO OBSERVED THAT THE PROXIMAL PART OF THE PLATE WAS SITTING SLIGHTLY POSTERIORLY EVEN THOUGH CLINICALLY WHICH SHE FELT IT NEEDED TO IN ORDER TO ACCOMMODATE THE FRAGMENT PATTERN EVEN THOUGH IT SEEMED DIRECTLY MEDIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427086 ↗
• MalfunctionJul 27, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE INSPECTING A DEPTH GAUGE. IT WAS ROUGH DURING THE SLIDING ADJUSTMENT. REPLACEMENT IS REQUESTED. NO PATIENTS OR HOSPITALS WERE INVOLVED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404588 ↗
• MalfunctionJun 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE STEM TO THE DEPTH GAUGE WAS BENT. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197905 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.        THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR SMALL SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965650 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON MARCH 30, 2023, THE HOOK WAS BENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763774 ↗
• MalfunctionFeb 21, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEPTH GAUGE IN QUESTION WAS FOUND TO HAVE A TWISTED HOOK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409440 ↗
• MalfunctionFeb 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: CUSTOMER REPORTED A NOTICEABLE NUMBER OF ISSUES WITH VARIOUS LENGTH MEASURING DEVICES DURING THE LAST WEEKS. DESPITE CORRECT REPROCESSING AND CARE, INSTRUMENTS "HOOK" AGAIN AND AGAIN, DO NOT RUN SMOOTHLY AND THUS COMPLICATE THE SURGERIES OR EXTEND THE SURGERY TIME BECAUSE NEW TRAYS HAVE TO BE OPENED AGAIN. THE USED CLEANER IS "MEDICLEAN FORTE" FROM THE COMPANY DR. WEIGERT. THE CUSTOMER NOW ASKS FOR A CHECK OF THE INSTRUMENTS, SINCE THE LENGTH MEASURING INSTRUMENTS HAVE TO BE ORDERED ON A WEEKLY BASIS, WHICH IS NOT A PERMANENT SOLUTION IN A HOSPITAL LIKE THIS (MAXIMUM CARE PROVIDER). THERE HAS BEEN NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292093 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: CUSTOMER REPORTED A NOTICEABLE NUMBER OF ISSUES WITH VARIOUS LENGTH MEASURING DEVICES DURING THE LAST WEEKS. DESPITE CORRECT REPROCESSING AND CARE, INSTRUMENTS "HOOK" AGAIN AND AGAIN, DO NOT RUN SMOOTHLY AND THUS COMPLICATE THE SURGERIES OR EXTEND THE SURGERY TIME BECAUSE NEW TRAYS HAVE TO BE OPENED AGAIN. THE USED CLEANER IS "MEDICLEAN FORTE" FROM THE COMPANY DR. WEIGERT. THE CUSTOMER NOW ASKS FOR A CHECK OF THE INSTRUMENTS, SINCE THE LENGTH MEASURING INSTRUMENTS HAVE TO BE ORDERED ON A WEEKLY BASIS, WHICH IS NOT A PERMANENT SOLUTION IN A HOSPITAL LIKE THIS (MAXIMUM CARE PROVIDER). THERE HAS BEEN NO PATIENT HARM. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279761 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: CUSTOMER REPORTED A NOTICEABLE NUMBER OF ISSUES WITH VARIOUS LENGTH MEASURING DEVICES DURING THE LAST WEEKS. DESPITE CORRECT REPROCESSING AND CARE, INSTRUMENTS "HOOK" AGAIN AND AGAIN, DO NOT RUN SMOOTHLY AND THUS COMPLICATE THE SURGERIES OR EXTEND THE SURGERY TIME BECAUSE NEW TRAYS HAVE TO BE OPENED AGAIN. THE USED CLEANER IS "MEDICLEAN FORTE" FROM THE COMPANY DR. WEIGERT. THE CUSTOMER NOW ASKS FOR A CHECK OF THE INSTRUMENTS, SINCE THE LENGTH MEASURING INSTRUMENTS HAVE TO BE ORDERED ON A WEEKLY BASIS, WHICH IS NOT A PERMANENT SOLUTION IN A HOSPITAL LIKE THIS (MAXIMUM CARE PROVIDER). THERE HAS BEEN NO PATIENT HARM. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279759 ↗
• MalfunctionDec 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING INTRA-OP IT WAS NOTICED THAT THE DEPTH GAUGE IN QUESTION WAS VERY BENT AND REQUIRES REPLACEMENT. THE SURGEON USED A PAIR OF PLIERS TO STRAIGHTEN THE DEPTH GAUGE AND CONTINUED TO USE IT, COMPLETING THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, AND NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A DEPTH GAUGE FOR SMALL SCREWS THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995406 ↗