NA 319.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982190017), received between Aug 27, 2019 and Mar 20, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 24651769 ↗
• 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 24651767 ↗
• 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 24651735 ↗
• 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 24642682 ↗
• MalfunctionJun 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED AN INSTRUMENT WAS FOUND TO BE MISSING A COMPONENT ON RETURN INSPECTION. THE PRODUCT DAMAGE DOCUMENTED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177268 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THREE DEPTH GAUGES ARE NO LONGER USABLE. THE LARGE FRAG DEPTH GAUGE APPEARS TO BE MISSING THE TIP. OTHER THAN THAT, THE DEPTH GAUGE IS IN GOOD SHAPE. FOR THE OTHER TWO 3.5 PELVIC DEPTH GAUGES, THERE IS A BALL AND SPRING MECHANISM THAT APPEARS TO HAVE FALLEN OUT DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399074 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE BENT TIP OF DEPTH GAUGE WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20675516 ↗
• MalfunctionSep 9, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2024 THE BALL IS LOOSE; BROKEN. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170157 ↗
• MalfunctionJan 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT IN (B)(6) 2023, AFTER VISUAL EXAMINATION, THE DEVICES WERE FOUND TO HAVE THE FOLLOWING CONDITIONS: BENT, BROKEN, AND/OR STRIPPED. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18474397 ↗
• 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 (B)(6). 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 LARGE SCREWS. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279765 ↗
• MalfunctionDec 12, 2022Break; Material Deformation; Break; Material Deformation

  T WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY IT WAS NOTICED THAT THE LARGE FRAG DEPTH GAUGE WAS BROKEN X2. HOOKS WERE WORN DOWN AND NOT CATCHING ON THE CORTEX. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15962717 ↗
• MalfunctionDec 12, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY IT WAS NOTICED THAT THE LARGE FRAG DEPTH GAUGE WAS BROKEN X2. HOOKS WERE WORN DOWN AND NOT CATCHING ON THE CORTEX. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961395 ↗
• MalfunctionNov 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2022 DURING ASSEMBLY, THE DEPTH GAUGE HOOK WAS FOUND TO BE FACING THE WRONG DIRECTION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763008 ↗
• MalfunctionNov 7, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 14-OCTOBER-2022, WHILE USING THE LARGE FRAGMENT DEPTH GAUGE, THE DEPTH GAUGE FELL APART. THE SURGEON ELECTED TO USE A SMALL FRAGMENT DEPTH GAUGE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE THREADS OF THE NUT DID NOT ALLOW THE NUT TO SCREW IN ALL THE WAY. NO SURGICAL DELAY WAS REPORTED, NO FRAGMENTS WERE GENERATED, AND NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR A DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743167 ↗
• MalfunctionAug 17, 2022Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE IN QUESTION WAS RETURNED FROM STERILE SERVICES WITH TIP MISSING. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242650 ↗
• MalfunctionDec 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET AT A FIELD STOCKING LOCATION (FSL) ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DEPTH GAUGE FOR LARGE SCREWS WAS MISSING A COMPONENT. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE NEEDLE OF THE DEVICE WAS BENT. THIS REPORT IS FOR A DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975429 ↗
• MalfunctionSep 27, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF THE LOANER SET, IT WAS OBSERVED THAT THE DEPTH GAUGE FOR LARGE SCREWS WAS MISSING A COMPONENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533734 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE FIELD SERVICE LOCATION, IT WAS OBSERVED THAT THE DEPTH GAUGE WAS BENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700274 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS IT WAS NOTICED THAT ONE OF THE DEPTH GAUGE AND THE TIP WAS BENT AND UNUSABLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678080 ↗
• MalfunctionNov 30, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEPTH GAUGE LARGE SCREWS PROBE IS LOOSE AND WIGGLING. IT WAS UNABLE TO TAKE ACCURATE MEASUREMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924179 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 9 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192471 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 7 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192462 ↗
• MalfunctionAug 27, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DEPTH GAUGE WAS OBSERVED TO HAVE A MISSING PIECE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936282 ↗