NA 319.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10887587039008), received between Oct 31, 2018 and Nov 4, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE TIP OF DEPTH GAUGE 319.006 WAS BROKEN AND IT WAS HARD TO SLIDE THE OUTER SLEEVE DEPTH GAUGE 319.007 AND THERE WAS A BROKEN TIP 4 HEX SCREWDRIVER. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598461 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SURGERY IT WAS NOTICED THAT THE DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG TIP BROKE OFF. IT WAS UNKNOWN THAT ANY FRAGMENTS GENERATED OR NOT. IT WAS ALSO UNKNOWN IF THAT SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330194 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 10 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959879 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR (1) DEPTH GAUGE. THIS IS REPORT 8 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959723 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 7 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959721 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 6 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959688 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 5 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959532 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 4 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959401 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 3 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959370 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT SIXTEEN (16) DEPTH GAUGES WERE DISCOVERED TO HAVE WEAR AND TEAR. THEY WERE GUMMY AND BENT. THESE DEPTH GAUGES HAVE NEVER BEEN REPLACED SINCE THE SETS WERE PLACED INTO SERVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 1 OF 16 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959294 ↗
• MalfunctionMar 30, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590116 ↗
• MalfunctionApr 17, 2020Break; Break

  IT WAS REPORTED THAT ON MARCH 24, 2020, THE DEPTH GAUGE WAS DISCOVERED BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9971913 ↗
• MalfunctionOct 4, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019 A TITANIUM (TI) MINI LOCKING PLATE AND A DEPTH GAUGE WERE FOUND BROKEN DURING THE AUDIT OF RETURNED DEVICES AT MILLSTONE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, LONG. THIS IS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9156682 ↗
• MalfunctionOct 31, 2018Break; Break

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE, HANDLE WITH QUICK COUPLING, TWO (2) HEXAGONAL SCREWDRIVER, AND DYNAMIC HIP SYSTEM/DYNAMIC CONDYLAR SYSTEM GUIDE SHAFT WERE TAGGED AS BROKEN IN MEDICAL DEVICE REPROCESSING DEPARTMENT (MDRD). THERE WERE NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8025164 ↗