NA 319.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10886982189936), received between Dec 28, 2016 and May 1, 2026 — classified as 1 injury, 81 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED INSTRUMENTS HAVE BROKEN FROM CASE USAGE. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056293 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED INSTRUMENTS HAVE BROKEN FROM CASE USAGE. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056252 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BROKEN. THIS OCCURRED IN THE PRE-OP SETTING AND NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496852 ↗
• MalfunctionMar 2, 2026Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DEPTH GAUGES WERE STICKY AND DID NOT SLIDE WELL. STERILE SCREW WAS OPENED AND WAS DROPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489280 ↗
• MalfunctionJul 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR THE DISTAL END OF THE RADIAL & ULNAR FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE EVENT DID NOT IMPACT SURGERY THE J&J¿S DISTRIBUTOR FOUND THAT THE TIP OF THE DEPTH GAUGE WAS BROKEN WHEN DELIVERY TO THE HOSPITAL. THE DEPTH GAUGE WAS NOT USED IN THE SURGERY. THIS EVENT DIDN¿T AFFECT THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505811 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE BROKE OFF. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413291 ↗
• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE ISN¿T STRAIGHT AND NOT FUNCTIONING PROPERLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063095 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE BROKE DURING INSERTION. SURGERY WAS DELAYED BY TWO MINUTES DUE TO THE EVENT. A REPLACEMENT DEPTH GAUGE WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853667 ↗
• MalfunctionSep 10, 2024Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ON AUG 20, 2024 THE BALL IS LOOSE. BROKEN. IT WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185843 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PROVE IS DAMAGED ON ITEM IN DEPTH GAUGE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650402 ↗
• MalfunctionJun 10, 2024Break; Corroded; Mechanical Jam; Break; Corroded; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE END OF A DEPTH GAUGE IS BROKEN, RUSTED, AND NOT USABLE. MIDDLE BLACK PIECE WILL NOT SLIDE/MOVE FOR MEASUREMENTS AS WELL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505111 ↗
• 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 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960568 ↗
• MalfunctionMar 14, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, A DEPTH GAUGE BROKE. THE DEVICE DID NOT SLIDE PROPERLY. AN ALTERNATIVE DEVICE WAS USED. THERE WERE NO BROKEN FRAGMENTS INVOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO TO THREE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907324 ↗
• MalfunctionOct 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INSTRUMENTS NEEDING REPAIR. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE ON SEPTEMBER 21, 2023, IT WAS IDENTIFIED THAT THE NEEDLE OF THE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS WAS DEFORMED/BENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878313 ↗
• MalfunctionOct 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INSTRUMENTS NEEDING REPAIR. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023, IT WAS IDENTIFIED THAT THE NEEDLE OF THE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS WAS DEFORMED/BENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878302 ↗
• MalfunctionSep 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE TURNING OVER SETS, I NOTICED TWO DEPTH GAUGES HAD ISSUES. THE 3.5 DEPTH GAUGE HAD ISSUES WITH THE NUT SCREWING ON ALL THE WAY AND THE 1.3/1.5 DEPTH GAUGE WAS VERY ROUGH WHILE SLIDING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764996 ↗
• MalfunctionAug 24, 2023Break; Incorrect Measurement; Break; Incorrect Measurement

  IT WAS REPORTED THAT ON (B)(6) 2023, A SCREW DRIVER HANDLE WOULD NOT NOT CONNECT TO THE DRIVE SHAFTS. ANOTHER HANDLE WAS USED INSTEAD. A SCREW WAS PUT IN THAT WAS TOO LONG. IT WAS NOTICED THAT THE DEPTH GAUGE WAS MEASURING INACCURATE, AND ULTIMATELY THE TIP OF THE DEPTH GAUGE HAD BEEN BROKEN OFF AT SOME POINT LIKELY NOT DURING THIS SURGERY BUT UNCERTAIN. THE SURGEONS USED A DIFFERENT DEPTH GAUGE TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE EVENTS OCCURRED. DURING THIS SURGERY, THE SURGEON PLACED CEMENT AND AN EX FIX AND WILL BRING BACK TO PATIENT TO REMOVE THE EX FIX AND PERFORM AN ORIF OF A THUMB IN THE FUTURE. THERE WAS 5 MIN SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613218 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, A DEPTH GAUGE FROM SPD WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCES. IT WAS UNKNOWN WHEN WAS THE EVENT OCCURRED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280333 ↗
• MalfunctionNov 30, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY WITH THE PRODUCT IN QUESTION. UPON DELIVERY, IT WAS DISCOVERED PREOPERATIVELY THAT THE TIP OF THE 319-004 DEPTH GAUGE WAS BROKEN. THE SURGERY WAS HANDLED BY A HOSPITAL-OWNED DEPTH GAUGE. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885066 ↗
• MalfunctionOct 24, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON ROUTINE INSPECTION POSTOPERATIVELY, IT WAS OBSERVED THAT THE DEPTH GAUGE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660190 ↗
• MalfunctionJul 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6)2022THE DEPTH GAUGE DID NOT SLIDE APPROPRIATELY AND SCREWDRIVER WITH HOLDING SLEEVE DID NOT HOLD SCREWS PROPERLY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079907 ↗
• MalfunctionJul 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DEPTH GAUGE WAS FOUND TO BE DAMAGED DURING ROUTINE INSPECTION PRIOR TO STERILIZATION. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR A DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957768 ↗
• MalfunctionJun 28, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS WAS BENT. THERE WAS NO PATIENT OR SURGEON INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840918 ↗
• MalfunctionJun 9, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE 1.3/1.5MM DEPTH GAUGE FOR MODULAR HAND SYSTEM WAS BENT. IT MADE THE DEPTH GAUGE ALMOST INEFFECTIVE MEASURING THROUGH THE DRILL HOLE AS IT COULD NOT PASS THROUGH IN ITS ENTIRETY IN ORDER TO GIVE AN ACCURATE MEASUREMENT. CONCOMITANT DEVICE REPORTED: UNK DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN)/. THIS COMPLAINT INVOLVES ONE (1) DEVICE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643990 ↗
• MalfunctionMar 24, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE HAD A BROKEN TIP. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895453 ↗