NA 72202998Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885554017670), received between Jul 24, 2018 and Jul 23, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A BILATERAL HIP ARTHROSCOPY, THE NITINOL GUIDEWIRE 1.2MM X 45CM EXPERIENCED STRESS AND BROKE IMMEDIATELY AS SOON AS THE WIRE WAS INSERTED WHEN THE DOCTOR LOWERED THE METAL CANNULA OVER THE WIRE. THE REMAINING ARTICULAR PIECE (5 CM) WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES AND NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576151 ↗
• InjuryNov 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THERE WAS SOME RESISTANCE WHEN INTRODUCING THE CANNULA INTO THE NITINOL GUIDEWIRE AND THE WIRE BROKE. THE WIRE WAS REMOVED COMPLETELY FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE. PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856766 ↗
• InjuryMar 29, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, AT THE TIME OF PLACING THE FEMORAL SCREW, THE 'NITINOL GUIDE WIRE' BROKE, IT WAS VERIFIED DURING THE PROCEDURE AND THE PIECE OF THE INTRA-ARTICULAR GUIDE COULD NOT BE SEEN. THE SPECIALIST SUBSEQUENTLY REMOVED THE NITINOL GUIDE PIECE WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING THE SAME DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934920 ↗
• InjuryDec 22, 2020Break; Break

  IT WAS REPORTED THAT, IN AN ARTHROSCOPY, WHEN INTRODUCING THE GD WIRE NITINOL, THE METALLIC CANNULA WAS INSERTED BUT THE INTRODUCER WAS RELEASED FROM THE CANNULA AND THE DOCTOR THREADED THE INTRODUCER WITH THE WIRE IN THE JOINT. THE FORCE THAT WAS USED TO PLACE THE CANNULA BROKE THE NITINOL TIP INSIDE THE PATIENT. THE BROKEN WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY OF 40 MIN. 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 11056094 ↗
• MalfunctionNov 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WHEN PASSING THE WIRE THROUGH THE NEEDLE, THE GUIDE WIRE BROKE INSIDE THE PATIENT. BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9378844 ↗
• MalfunctionJul 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY BY INSERTING THE NITINOL WIRE AND PLACING THE CANNULA ON THE WIRE, IT BROKE. IT WAS REMOVED WITH GRASPER. NO BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815951 ↗
• MalfunctionJul 24, 2018Break

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE NITINOL GUIDE PIN WAS PLACED, IT WAS BROKEN, AND WAS REMOVED WITHOUT CAUSING DAMAGE TO THE PATIENT. FINALLY A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713946 ↗