NA 319.091Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10886982190000), received between Mar 24, 2017 and Aug 13, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Incorrect Measurement; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237630 ↗
• MalfunctionApr 6, 2026Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 THE DEPTH GAUGE WAS FOUND TO BE BROKEN BY THE SPD STAFF. THE BALL BEARING HAS FALLEN OUT (UNABLE TO LOCATE), SO THE OUTER SLEEVE JUST FALLS OFF OF THE DEPTH GAUGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794770 ↗
• MalfunctionMar 9, 2026Use of Device Problem

  IT WAS REPORTED THAT THE DEPTH GAUGE IS MISSING SMALL SILVER BALL ON SIDE OF DEVICE. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545312 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED MULTIPLE DEVICES ARE NO LONGER FUNCTIONAL. THESE ISSUES DID NOT IMPACT PATIENT OUTCOMES. BELOW DEVICES WERE FOUND TO BE "RELEASE MECHANISM BROKEN" DURING INSPECTION: 03.043.028. BELOW DEVICES WERE FOUND TO BE "STRIPPED THREADS" DURING INSPECTION: 03.120.022, 312.648, 323.029. BELOW DEVICES WERE FOUND TO BE "NUT STUCK ON SLEEVE" DURING INSPECTION: 03.037.017, 03.037.016. BELOW DEVICES WERE FOUND TO BE "HANDLE LEACHING/SPD WIL NOT STERILIZE" DURING INSPECTION: 03.100.018. BELOW DEVICES WERE FOUND TO BE "BROKEN HANDLE" DURING INSPECTION: 311.43. BELOW DEVICES WERE FOUND TO BE "STRIPPED DRILL CONNECTION AND 2ND IS COLD WELDED TO A SCHANZ PIN" DURING INSPECTION: 393.103. BELOW DEVICES WERE FOUND TO BE "BROKEN SLIDING MECHANISM" DURING INSPECTION: 319.091. BELOW DEVICES WERE FOUND TO BE "NOT SNAPPING IN" DURING INSPECTION: 03.120.018, 03.120.017. BELOW DEVICES WERE FOUND TO BE "STRIPPED" DURING INSPECTION: 03.010.151, 314.467, 03.900.042, 03.130.010, 314.453, 03.010.150, 03.010.152. BELOW DEVICES WERE FOUND TO BE "NOT WORKING PROPERLY" DURING INSPECTION: 329.15. BELOW DEVICES WERE FOUND TO BE "NOT LOCKING TENSION BETWEEN TRIGGER PULLS" DURING INSPECTION: 03.221.015. BELOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179477 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT ONE DEPTH GAUGE BROKE DURING SURGERY AND THE OTHER DID NOT FIT THROUGH DRILL HOLE. NO SURGICAL DELAY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680923 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE HOOK IS BROKEN FROM USAGE IN PELVIS. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751311 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE HOOK IS BROKEN FROM USAGE IN PELVIS. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751308 ↗
• MalfunctionAug 8, 2025Break; Break

  THE FOLLOWING PRODUCT ISSUES WERE REPORTED TO HAVE OCCURRED ON AN UNKNOWN DATE: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS (X 3) - HOOK IS BROKEN FROM USAGE IN PELVIS. RATCHET WRENCH-11MM WIDTH ACROSS FLATS (X 3) - RATCHET DOESN¿T WORK. 2.4/2.7 VOLT(TM) SCR RACK 6-90 2 HIGH 1/3 WIDTH ALUM FRAME (X 2) - RACKS ARE FADED FROM WASH AND SOAP. 1.6MM/0.8MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2.0MM/1.1MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2.7MM COMPRESSION/DISTRACTION POST/FOR VA-LOCKING HOLE X 6- THREADS ARE STRIPPED. 2.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP (X 6)- THREADS STRIPPED. 2.7MM VOLT(TM) CONDYLAR PLATE 6H/58MM (X 1) - PLATE DID NOT LOCK WITH LOCKING SCREW. 2.7MM VOLT(TM) CONDYLAR PLATE 10H/95MM (X 1) PLATE DID NOT LOCK WITH LOCKING SCREW. 15.5MM MONOBLOC FLEXIBLE REAMER - LONG (X 2) - REAMERS ARE DULL. PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE (X 3)- RUST ON ELEVATOR. THERE WAS NO PATIENT INVOLVEMENT; ISSUES WERE NOTED IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748421 ↗
• MalfunctionAug 1, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT BENT/BROKEN DEPTH GAUGES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686686 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873284 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 2025, DURING A SURGERY, FIVE PROXIMAL HUMERUS SLEEVES WERE USED. THE DRILL BIT WAS USED THROUGH FIVE SLEEVES AND SEEMED TO BEND OR WARP THE SLEEVES. THE POWER SHAFT NEEDED TO BE REMOVED THROUGH THE SLEEVE. FIVE WERE USED. THE DEPTH GAUGE WAS ALSO USED AND THE HOOK WAS SUPER BENT ON TWO OF THE DEPTH GAUGES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873262 ↗
• MalfunctionFeb 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WAS PITTING/CHIPPING ON THE TIP OF THE MONOBLOC FLEXIBLE REAMER. ALSO, THE DEPTH GAUGE WAS BENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354897 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR A PELVIC FRACTURE ON PELVIC WITH THE DEPTH GAUGE IN QUESTION. IN THE SURGERY, THE TIP OF THE PRODUCT BROKE OFF. THE BROKEN END WAS QUICKLY RETRIEVED AND SURGERY RESUMED USING ANOTHER DEPTH GAUGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867178 ↗
• MalfunctionSep 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE FROM THE PELVIS SET IS BENT AND DAMAGED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT/CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189395 ↗
• MalfunctionJul 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A TNA, POLYMER SHIFTED, SURGEON TRIED TO REMOVE IT WITH A DEPTH GAUGE. DURING REMOVAL, TWO IM NAIL DEPTH GAUGES AND A PELVIC DEPTH GAUGE WERE EXTREMELY BENT. THE WRENCH WAS ALSO USED TO HIT THE NAIL TO BANG IT OUT BUT IT SCARIFIED THE WRENCH. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715509 ↗
• MalfunctionJun 27, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS ON THE DEPTH GAUGE ARE BENT BACKWARDS OR BROKEN. THERE WERE NO PATIENT INVOLVEMENT OR PATIENT STATUS/OUTCOME/CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 3 OF 3 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625036 ↗
• MalfunctionJun 27, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS ON THE DEPTH GAUGE ARE BENT BACKWARDS OR BROKEN. THERE WERE NO PATIENT INVOLVEMENT OR PATIENT STATUS/OUTCOME/CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624964 ↗
• MalfunctionJun 27, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS ON THE DEPTH GAUGE ARE BENT BACKWARDS OR BROKEN. THERE WERE NO PATIENT INVOLVEMENT OR PATIENT STATUS/OUTCOME/CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624958 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PELVIC PLATING CASE, THE DEPTH GAUGE HOOK WAS NOT CATCHING ON FAR CORTEX BECAUSE THE TIP BROKE OFF. THIS REPORT IS FOR A DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19614264 ↗
• MalfunctionMar 22, 2024Break; Incorrect Measurement; Material Deformation; Break; Incorrect Measurement; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE TIPS OF THE DEPTH GAUGES WERE FOUND TO BE BENT AND/OR BROKEN AT THE SHAFT. THE PRODUCTS WERE UNABLE TO GIVE ACCURATE LENGTH READINGS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 2 MINUTES BY USING REPLACEMENT DEPTH GAUGES. NO FRAGMENTS WERE GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960571 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SALES REP HAD BROKEN INSTRUMENTS. THE SALES REP WAS TRYING TO EXCHANGE ON WARRANTY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618739 ↗
• MalfunctionJan 17, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE 11/8 SLEEVE PROTECTION GETS STUCK IN SURGERY WITH DRILL SL 4.2 AND SYREAM 2.5 L950 DRILL GUIDE AND BENDS IN SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DEPTH GAUGE F/CORTSCR Ø3.5 MEAS-RANGE UP THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18531314 ↗
• MalfunctionJan 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE WAS BENT, AND THE STRIKING CAP THREADS WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503312 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PIECE OF DEPTH GAUGE WAS BROKEN OFF, RENDERING IT DIFFICULT TO USE, AND "SLEEVE" OF DEVICE TO SLIP OFF (SLEEVE OF DEVICE THEREFORE WAS LOST). NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310836 ↗
• MalfunctionDec 5, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE PRODUCTS IN QUESTION WERE BROKEN DURING ORTHO CASES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DEPTH GAUGE FOR 3.5MM CORTEX SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267659 ↗