NA 03.118.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982073365), received between Jan 29, 2020 and Aug 15, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PERCUTANEOUS DEPTH GAUGE FROM VA ELBOW SET IS BENT AND NO LONGER GLIDES THRU DRILL HOLES TO MEASURE LONG SCREWS. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815316 ↗
• MalfunctionJun 24, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE DEPTH GAUGE IS STICKING. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323788 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY ON (B)(6) 2024. BEFORE THE SURGERY DURING INSTRUMENT PREPARATION, THE PART OF THE DEPTH GAUGE OPERATED BY THE THUMB CAME OFF EASILY. EVEN AFTER PUTTING THE DISLODGED PART BACK ON, THE HAND OPERATED PART OF THE DEPTH GAUGE FELT LOOSE, SO A NEW PRODUCT WAS ARRANGED. THIS DID NOT AFFECT THE SURGERY; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751476 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, A DEPTH GAUGE MEASURING WIRE BROKEN. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR A PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706265 ↗
• MalfunctionOct 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY TREATING THE DISTAL END OF THE HUMERUS. WHEN THE SURGEON USED THE DEPTH GAUGE AFTER INSERTING SOME 2.7 MM VA LOCKING SCREWS, THE SURGEON NOTICED THAT THE TIP OF THE DEPTH GAUGE WAS BENT. THE EVENT DID NOT AFFECT THE SURGERY BECAUSE THE DEPTH GAUGE WAS NOT NEEDED TO BE USED AFTER THE BENT WAS FOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950363 ↗
• MalfunctionOct 21, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE TIP OF THE ITEM WAS BENT AND INCORRECTLY ALIGNED. THE ITEM WAS DEEMED TO BE NO LONGER FUNCTIONAL AND WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651288 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN THE STERILE PROCESSING DEPARTMENT (SPD) IT WAS NOTICED, THAT THE TIP DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE PERCUTANEOUS DEPTH GAUGE FOR 2.7 SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577926 ↗
• MalfunctionJan 7, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, SINCE THE START OF THE PROCEDURE, THE PERCUTANEOUS DEPTH GAUGE HAS ABNORMAL TIP TORQUE AND IS VERY DIFFICULT TO MEASURE THE SCREWS NEEDED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196675 ↗
• MalfunctionMar 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. THE PERCUTANEOUS DEPTH GAUGE, DEPTH GAUGE FOR LOCKING SCREWS, AND DEPTH GAUGE FOR CORTEX SCREWS WERE BENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THIS REPORT INVOLVES ONE (1) PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 5 OF 8 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413272 ↗
• MalfunctionOct 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE PERCUTANEOUS DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10613202 ↗
• MalfunctionSep 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE PERCUTANEOUS DEPTH GAUGE FOR 2.7 MM SCREWS WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERCUTANEOUS DEPTH GAUGE FOR 2.7 MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551165 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2019, THE PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9644774 ↗