NA 319.11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982190024), received between Apr 8, 2019 and Feb 3, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING CASE. IT WAS ISSUES WITH BOTH RATCHETING HANDLE AND DEPTH GAUGE, THE DEPTH GAUGE WAS VERY STICKY. THERE WAS NO SURGICAL DELAY AND NO REPORTED PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR MINI SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293486 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A VETERINARY PROCEDURE, THE TIP OF THE DEPTH GAUGE WAS BROKEN OFF. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. FRAGMENTS OF THE BROKEN DEVICE WERE GENERATED WITH UNKNOWN ADDITIONAL INTERVENTION AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR MINI SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974495 ↗
• MalfunctionSep 17, 2020Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE FOR MINI SCREWS LOST A PART AND NEED IT REPAIRED. THE EVENT DID NOT OCCUR DURING ANY SURGICAL PROCEDURES AND NO PATIENTS WERE AFFECTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR MINI SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10547917 ↗
• MalfunctionMay 20, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2019, A DEPTH GAUGE WAS HARD TO TAKE APART TO CLEAN AND MAINTAIN. ISSUE WAS NOTICED DURING CLEANING PROCESS OF THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8624953 ↗
• MalfunctionApr 8, 2019Break; Break

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON (B)(6) 2019, THE DEPTH GAUGE FOR MINI SCREWS BROKE OFF WHILE CLEANING. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR MINI SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8492251 ↗