NA 03.010.428Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886982068699), received between May 24, 2019 and Mar 6, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (37 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Deformation

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531406 ↗
• MalfunctionMar 5, 2026Material Deformation

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518803 ↗
• MalfunctionMar 5, 2026Material Deformation

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518797 ↗
• MalfunctionMar 5, 2026Material Deformation

  IT WAS REPORTED DEPTH GAUGES WERE BENT AND COULD NOT BE USED FOR ACCURATE MEASUREMENT, LENGTH INDICATORS ON SCREW CADDIES WERE COMING OUT MAKING IT DIFFICULT TO QUICKLY FIND THE CORRECT SCREW LENGTH, AND THREADS ON THE TFNA LAG SCREW EXTRACTOR WERE STRIPPED. THESE ISSUES WERE DISCOVERED WHEN TRAYS WERE BEING REASSEMBLED AFTER CASES; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518784 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026 THERE WAS AN ISSUE IN PRE-OP WHEN SETTING UP FOR A TIBIAL NAIL. THE AIMING SHOWED SIGNS OF WEAR ON THE LEVER HANDLE, IT HAD A CRACK IN IT. THE DEPTH GAUGE THAT WAS USED WAS ALSO BENT AND COULD NOT BE STRAIGHTENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457084 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE MEASURING PROBE OF THE DEPTH METER IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593988 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  DURING THE PROCEDURE, WHEN THE COMPACT AIR DRIVE MOTOR WAS BEING USED, IT LOST GRIP, LOSING STRENGTH AND POWER. SEEKING A PROMPT SOLUTION, A MOTOR WAS LOANED FROM THE CLINIC, ALLOWING THE SURGERY TO PROCEED WITHOUT INCIDENT. DURING THE SURGERY, IT WAS ALSO EVIDENT THAT THE DEPTH GAUGE'S TIP WAS BENT, SO THE SPECIALIST REQUESTED THAT IT BE CHECKED OR REPLACED. THE SPECIALIST DID NOT EXPERIENCE ANY DISCOMFORT. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY HARM TO THE PATIENT OR ALTERATIONS IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290594 ↗
• MalfunctionJun 23, 2025Break; Material Deformation; Illegible Information; Break; Material Deformation; Illegible Information

  ADDITIONAL INFORMATION RECEIVED STATES THAT DEPTH GAUGE MEASUREMENTS WERE ILLEGIBLE AND THE TIP OF THE DEPTH GAUGE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310270 ↗
• MalfunctionMay 27, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING THE SURGERY, THE GAUGE BENDS AND THEN UNCOUPLES FROM ITS FITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090579 ↗
• MalfunctionMay 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE IS TWISTED. SURGEON IS NOT SURE OF THE SIZE OF THE SCREWS BECAUSE OF THE GAUGE.

  Patient problems: Insufficient Information

  MAUDE report 21963250 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT DEPTH GAUGE TIP BROKE OFF DURING SURGERY AT (B)(6) 2025. NO PATIENT CONSEQUENCES OR DELAY WAS REPORTED. ITEM AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911461 ↗
• MalfunctionApr 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY WITH DEPTH GAUGE. THE DRILLING FOR DISTAL SCREW WAS NOT THROUGH OUT TO THE CORTEX OF THE OTHER SIDE. SO, WHEN THE SURGEON INSERTED THE DEPTH GAUGE, TIP OF THE DEPTH GAUGE GOT BENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910476 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE BEING USED IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR PATIENT RESULTING FROM EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644860 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DEPTH GAUGE WAS FOUND BROKEN PRE-OPERATIVELY WHEN THE SCRUB TECH WAS SETTING UP FOR THE CASE. THERE WAS NO PATIENT INVOLVED. SURGERY WAS SUCCESSFULLY COMPLETED AND THERE WAS NO DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20682269 ↗
• MalfunctionMar 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 12-MARCH-2024 DURING ROUTINE INSPECTION IN STERILE PROCESSING, THE DEVICES IN QUESTION WERE FOUND TO BE DAMAGED. THE TIPS OF THE T8 SCREWDRIVERS IN QUESTION ARE DAMAGED, AND THE TIP OF THE LARGE DEPTH GAUGE IN QUESTION IS BENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT, THE EVENT DID NOT OCCUR DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985740 ↗
• MalfunctionFeb 20, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT APPARENTLY IT CAME BACK FROM STERILE SERVICE BROKEN AND NO ONE IS SURE HOW IT FAILED. THE SILVER SECTION HAS COME AWAY FROM THE SLIDING BLACK SECTION OF THE DEPTH GAUGE. DON¿T HAVE THE INSTRUMENT AND NO HARM CAME TO THE PATIENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE F/LOCK-SCR MEAS-RANGE - 110. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741725 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PIECE OF A DEPTH GAUGE BROKE OFF, CAUSING THE SLEEVE TO NO LONGER SIT/STOP CORRECTLY AND FALL OFF INAPPROPRIATELY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316965 ↗
• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF THE DEPTH GAUGES IN QUESTIONS WERE SEVERELY BENT. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067603 ↗
• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF THE DEPTH GAUGES IN QUESTIONS WERE SEVERELY BENT. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067599 ↗
• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF THE DEPTH GAUGES IN QUESTIONS WERE SEVERELY BENT. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067598 ↗
• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIPS OF THE DEPTH GAUGES IN QUESTIONS WERE SEVERELY BENT. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067596 ↗
• MalfunctionNov 2, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A DEPTH GAUGE WAS BENT AND SHOWED SIGNS OF WEAR AND TEAR. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062139 ↗
• MalfunctionNov 2, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A DEPTH GAUGE WAS BENT AND SHOWED SIGNS OF WEAR AND TEAR. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059907 ↗
• MalfunctionJul 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGEON NOTICED THAT THE DEPTH GAUGE SEVERELY BENT WHILE MEASURING FOR A SCREW, BUT CONTINUED TO USE THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424499 ↗
• MalfunctionMar 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE THERE WAS A INTER-PROSTHETIC FRACTURE WITH A DISTAL FEMUR FRACTURE. A FRN WAS INSERTED AND THEN TWO PLATES WERE INSERTED DISTALLY. A LATERAL PLATE WAS INSERTED AND THE SAME PLATE, BUT CONTRALATERAL SIDE WAS PUT ON THE MEDIAL SIDE. DURING THE FRN, THE PROXIMAL PORTION BECAME SNAGGED UP. THE DRIVE CAP BROKE DURING MALLEATING. WHILE INSERTING BOTH PLATES DISTALLY, THE CENTER HOLE DID NOT LOCK INTO THE PLATE. UNSURE IF IT WAS DUE TO THE TRAFFIC OF THE SCREWS, AND MAKING THE SCREWS SKIVE OFF AXIS. DEPTH GAUGE WAS ALSO BENT IN THE PROCESS OF MEASURING FOR SCREWS. THERE WERE FOUR (4) MINUTES OF SURGICAL DELAY. THIS COMPLAINT INVOLVES FIVE (5) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR LCKNG SCRS TO 100 THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649302 ↗