NA 014395Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010374684), received between Jul 14, 2020 and Aug 20, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, DURING DRILLING OF FEMORAL TUNNEL WITH THE 2.4MM PASSING PIN, THE SURGEON NOTICED SMALL SHARDS OF METAL THAT HAD COME OFF THE PASSING PIN. THE SHARDS OF METAL WERE REMOVED USING A SHAVER WITH SUCTION; HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM IF ALL THE SHARDS WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH THE SAME REPORTED DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S CURRENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850866 ↗
• InjurySep 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE SURGERY, A 2.4 PASSING DRILL BIT LEFT MANY SMALL METAL SHARDS IN THE JOINT AFTER DRILLING OVER THE TOP WITH 4.5 CANNULATED DRILL BIT, SAME HAPPENED WITH A 2.4 MM PASSING PIN, THAT LEFT METAL SHARDS DURING OVER-DRILLING WITH THE 7.5 REAMER. SURGEON WAS ABLE TO REMOVE SHARDS FROM PATIENT. SURGERY WAS COMPLETED AFTER NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464706 ↗
• InjuryDec 21, 2020Break; Break

  IT WAS REPORTED THAT, DURING THE PROCEDURE, WHEN THE SURGEON TOOK THE "2.4MM PASSING PIN" OUT OF THE PATIENT'S BODY, HE NOTICED THAT IT GOT BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11052527 ↗
• InjuryJul 14, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, WHEN THE SURGEON WAS DRILLING THROUGH THE FEMUR, THE TIP OF THE PASSING PIN BROKE OFF. NO SIGNIFICANT DELAY WAS REPORTED (<5 MINUTES). SMITH AND NEPHEW BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY. BROKEN PIECES WERE REMOVED USING TWEEZERS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10272108 ↗
• InjuryJul 14, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, WHEN THE SURGEON WAS DRILLING THROUGH THE TIBIA THE TIP OF THE 2.4MM PASSING PIN BROKE OFF. NO SIGNIFICANT DELAY WAS REPORTED (<5 MINUTES). SMITH AND NEPHEW BACK UP DEVICE WAS USED TO COMPLETE THE SURGERY AND THE BROKEN PIECES WERE REMOVED BY USING TWEEZERS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10272071 ↗