NA 03.133.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 10886982269690), received between Aug 11, 2020 and Sep 18, 2026 — classified as 4 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Break” (148 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 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829714 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721907 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676565 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327097 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261862 ↗
• MalfunctionJul 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747606 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS SNAPPED AND BROKEN WHILE IN USE. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611395 ↗
• MalfunctionJun 8, 2026Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT DISTAL HUMERAL OLECRANON FRACTURE REPAIR SURGERY ON OLECRANON. DURING SURGERY, TIP OF THE DEPTH GAUGE BROKE. BEFORE MEASUREMENT, THERE WAS AN IMPRESSION THAT THE TIP OF THE DEPTH GAUGE WAS SLIGHTLY BENT. AFTER MEASURING THE FIRST SCREW, THE SLEEVE GOT CAUGHT ON THE TIP OF THE DEPTH GAUGE. WHEN THE SURGEON ATTEMPTED TO ROTATE THE DEPTH GAUGE AND REINSERT IT INTO THE SLEEVE, THE TIP OF THE SLEEVE BROKE OFF. SCREW LENGTH WAS MEASURED USING DRILL NOTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426819 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT THE TIP OF DEPTH GAUGE BROKE OFF. ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25395024 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED A DEPTH GAUGE SNAPPED DURING SURGERY. ANOTHER DEPTH GAUGE WAS USED FROM ANOTHER SET. A MINIMAL AMOUNT OF SURGICAL DELAY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321589 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BROKEN AT THE TIP AND CANNOT MEASURE ACCURATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100468 ↗
• MalfunctionMay 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2026, BEFORE USE, THE TIP OF THE PRODUCT FOR BREAKAGE WAS CONFIRMED. THE SALES REP REVIEWED THE PHOTOS TAKEN AT THE TIME OF DELIVERY, AND THE CONDITION IS THE SAME, SUGGESTING THE PRODUCT WAS BROKEN FROM THE TIME OF SHIPMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095436 ↗
• MalfunctionApr 24, 2026Break; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN AT THE TIP AND COULD NOT MEASURE ACCURATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986956 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT UPON INSPECTION THE INSTRUMENT WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903105 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DEPTH GAUGE WAS BROKEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885626 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED ON MARCH 16, 2026, THAT THE SURGEON WAS USING DEPTH GAUGE FROM UNIVERSAL SMALL FRAG. ATTEMPTED TO WITHDRAW TIP OF DEPTH GAUGE FROM BONE AND THE TIP BROKE OFF. TIP WAS REMOVED AND A PEEL POUCHED DEPTH GAUGE WAS USED. NO, SURGICAL DELAYED DUE TO THE REPORTED EVENT. NO, FRAGMENTS GENERATED. NO, PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774564 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT THE HOOK TIP OF THE DEPTH GAUGE WAS FOUND BROKEN PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744874 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT BROKEN INSTRUMENTS. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544787 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484907 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484811 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT THE DEPTH GAUGE HAD 3 BROKEN PIECES OF THE ITEM, THE TIP. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420665 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS INSPECTED IN SPD AND IT WAS FOUND THAT THE DEPTH GAUGE TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366051 ↗
• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED THAT THE SURGEON REPORTED THAT THE DEPTH GAUGE WAS BENT. THE SURGEON WAS SPECIFICALLY TALKING ABOUT THE INTERIOR PIECE THAT IS INSERTED INTO THE BONE FOR MEASURING PURPOSES. THERE WAS NO REPORTED DELAY IN THE SURGERY, NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305744 ↗
• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED THAT A DEPTH GAUGE 2.7/3.5 0 - 60 HAD A BENT TIP DURING A SURGICAL PROCEDURE, RENDERING THE DEVICE UNUSABLE. THE EVENT DID NOT DELAY THE SURGERY, WHICH WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303456 ↗
• MalfunctionJan 30, 2026Break

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM IF TWO DEPTH GAUGES BROKE IN TWO SEPARATE EVENTS? - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222940 ↗