NA 03.424.090Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982335937), received between Apr 3, 2025 and Sep 29, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931280 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE WAS REPORTED BROKEN, ATTRIBUTED TO BREAKAGE DURING WASHING WHEN THE TIP POKED THROUGH HOLES IN THE SET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057031 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE WAS REPORTED BROKEN, ATTRIBUTED TO BREAKAGE DURING WASHING WHEN THE TIP POKED THROUGH HOLES IN THE SET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057019 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE WAS REPORTED BROKEN, ATTRIBUTED TO BREAKAGE DURING WASHING WHEN THE TIP POKED THROUGH HOLES IN THE SET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017426 ↗
• MalfunctionApr 1, 2026Material Deformation

  IT WAS REPORTED ON (B)(6) 2026 DURING AN ORIF OF FEMUR THE DRILL GUIDE BROKE AND WAS UNABLE TO USE. ALSO, VOLT DEPTH GAUGE STEM WAS BENT BEYOND REPAIR. BOTH INSTRUMENTS WERE REPLACED FROM OTHER SETS QUICKLY WITH MINIMAL DELAY TO THE CASE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758098 ↗
• MalfunctionFeb 17, 2026No Apparent Adverse Event

  IT WAS REPORTED AN INSTRUMENT WAS DISCOVERED DAMAGED WHEN UNPACKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365502 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THREE (3) DEPTH GAUGE TIP BROKE OFF IN CSPD DECONTAMINATION. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789180 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THREE (3) DEPTH GAUGE TIP BROKE OFF IN CSPD DECONTAMINATION. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789174 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THREE (3) DEPTH GAUGE TIP BROKE OFF IN CSPD DECONTAMINATION. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789172 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2025, THAT THE DEPTH GAUGE WAS RECEIVED BENT AND UNUSABLE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378685 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE 2.4/2.7 VOLT(TM) DEPTH GAUGE/ 0 TO 90MM WAS FOUND IN STERILE PROCESSING DEPARTMENT TO HAVE THE PLASTIC PIECE BROKEN AND FLAKING PLASTIC PIECES OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458691 ↗
• MalfunctionMay 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PRODUCT LISTED BELOW WAS RECEIVED DAMAGED IN ORIGINAL PACKAGING. DURING MANUFACTURING INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE NEEDLE TIP WAS BENT.

  Patient problems: Insufficient Information

  MAUDE report 21963654 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN DEPTH GAUGES IN SPD AND HANDLE. THIS EVENT HAPPENED DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945351 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A NEW VOLT SET AND WHEN PUTTING SET TOGETHER, THE ITEM HAD A BENT TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761327 ↗