ACCU-PASS 7210425Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010534460), received between Jun 30, 2020 and May 15, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN ACCU-PASS HAD PIN HOLES FROM THE INSIDE ALONG THE FLAT SIDE OF THE PACKAGING. AS THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324133 ↗
• MalfunctionJun 7, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE "ACCUPASS 45° (UPBEND, STERILE)" COULD NOT ROLL THE MONOFILAMENT OUT OF THE DEVICE WHEN IT WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952151 ↗
• MalfunctionFeb 15, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ACCU-PASS STR SHUTTLE 45 DEG UP DID NOT ADVANCE THE NYLON MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 11328034 ↗
• MalfunctionFeb 15, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ACCU-PASS STR SHUTTLE 45 DEG UP DID NOT ADVANCE THE NYLON MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 11328027 ↗
• MalfunctionFeb 15, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ACCU-PASS STR SHUTTLE 45 DEG UP DID NOT ADVANCE THE NYLON MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 11328023 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ACCU-PASS 45-DEGREE, UPBEND, STERILE METAL SHAFT CAME OUT OF THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP SMITH AND NEPHEW DEVICE. NO PATIENT INJURY OR OTHER 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 11278661 ↗
• InjuryNov 19, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING MENISCUS REPAIR PROCEDURE, WHEN THE OUT OF BOX WAS OPENED, THE STERILIZATION PACK SEAL OF THE ACCU-PASS 45-DEGREE DID NOT CLOSE FROM THE FIRST. THE DEVICE WAS USED ON THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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; No Information

  MAUDE report 10865731 ↗
• InjurySep 23, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE MONOFILAMENT WOULD NOT COME OUT OF THE ACCUPASS, RENDERING IT UNUSABLE. THERE WAS A DIFFERENT S&N DEVICE AVAILABLE, WHICH WAS USED AS BACKUP . NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10577890 ↗
• MalfunctionSep 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE PROCEDURE USING AN ACCU-PASS 45-DEGREE, WHEN THE NEEDLE WAS INSERTED INTO THE MENISCUS, THE MONOFILAMENT WOULD NOT COME OUT; THEREFORE, IT WAS NOT ABLE TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10497512 ↗
• MalfunctionJun 30, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT DURING SURGERY, THE MONOFILAMENT WOULD NOT COME OUT OF THE ACCU-PASS HENCE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10212262 ↗