NA 2351-0070Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327368154), received between Apr 28, 2023 and Jan 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Mechanical Jam; Mechanical Jam

  WHEN DISTAL DRILLING WAS PERFORMED, THE DRILL NO LONGER PASSED THROUGH THE DRILL SLEEVE. SINCE THE DRILL WAS STUCK IN THE DRILL SLEEVE, THE DRILL WAS TAPPED OUT WITH A HAMMER. BONE CHIPS CAME OUT ALONG WITH THE DRILL. THE SURGERY WAS COMPLETED USING ANOTHER SLEEVE AND DRILL TIP. AFTER THE SURGERY, THE DRILL WAS PASSED THROUGH THE SUBJECT DRILL SLEEVE WITHOUT ANY PROBLEM.

  Patient problems: Bone Shedding Debris

  MAUDE report 21107715 ↗
• MalfunctionDec 5, 2024Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  AS REPORTED: "THE SLEEVE DID NOT PASS THROUGH THE OBLIQUE HOLE IN THE TARGETING ARM FEMUR GT. THE BUTTON WAS PUSHED BUT THE SLEEVE DID NOT GO THROUGH. HAMMERING THE SLEEVE WHILE PRESSING THE BUTTON ONLY ADVANCED IT A LITTLE. WHEN PULLING OUT THE SLEEVE, IT COULD NOT BE MANUALLY PULLED OUT; THE SLEEVE HAD TO BE CLAMPED WITH PLIERS AND BEATEN OUT WITH A HAMMER. FINALLY, THE SCREW COULD NOT BE INSERTED INTO THE HOLE WHERE IT SHOULD BE INSERTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858865 ↗
• MalfunctionMay 6, 2024Break; Fracture; Device Difficult to Setup or Prepare; Mechanical Jam; Break; Fracture; Device Difficult to Setup or Prepare; Mechanical Jam

  AS REPORTED: "WHEN IT WAS PERFORMED THE CALIBRATION BEFORE NAIL INSERTION, THE SLEEVE WAS TOO HARD TO INSERT TO THE MOST PROXIMAL HOLE OF THE DEVICE. AND THE SURGEON GAVE UP SCREW INSERTING TO THAT HOLE. THE OTHER PROXIMAL HOLES OF THE DEVICE WERE ALSO CHECKED AND IT WAS FELT HARDER THAN USUAL. THE NAIL WAS INSERTED AS IT WAS AND INSERTED A SCREW INTO THE PROXIMAL OVAL HOLE, BUT THE SLEEVE WOULD NOT BE REMOVED FROM THE DEVICE. THE SURGEON PULLED ON THE SLEEVE AND THE SLEEVE BROKE OFF.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246940 ↗
• MalfunctionNov 28, 2023Crack; Insufficient Device Problem Information; Crack; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A DEFECTIVE SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 18221411 ↗
• MalfunctionNov 7, 2023Crack; Crack

  IT WAS REPORTED, THAT DURING CSSD WASHING. THE ¿PLASTIC¿ SECTION OF THE SLEEVE WAS FOUND TO BE CRACKED AND SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082276 ↗
• MalfunctionNov 7, 2023Crack; Crack

  IT WAS REPORTED THAT DURING CSSD WASHING THE ¿PLASTIC¿ SECTION OF THE SLEEVE WAS FOUND TO BE CRACKED AND SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082275 ↗
• MalfunctionOct 31, 2023Naturally Worn; Naturally Worn

  AS REPORTED: "AFTER DRILLING, THE GUIDE WAS FOUND TO BE DAMAGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037294 ↗
• MalfunctionOct 27, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "FOUND BROKEN INSTRUMENT IN STERILIZING DEPARTMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022430 ↗
• MalfunctionOct 5, 2023Break; Fracture; Break; Fracture

  AS REPORTED "SLEEVE BROKEN WHEN USING DURING CASE. OCCURRED WHEN MOVING SLEEVE IN AND OUT OF TARGETING DEVICE HOLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875578 ↗
• MalfunctionMay 3, 2023Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  AS REPORTED: "TISSUE PROTECTION SLEEVE LONG DID NOT COME OFF FROM ADJUSTING DEVICE AFTER SCREW INSERTION. IT WAS DAMAGED WHEN FORCIBLY PULLED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864756 ↗
• MalfunctionApr 28, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "A SLEEVE WAS INSERTED USING A DISTAL TARGETING DEVICE, BUT THE SLEEVE DID NOT REACH THE BONE AND COULD NOT BE DRILLED AND MEASURED. THE SCREW WAS INSERTED FREEHAND.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831678 ↗