ACCU-PASS 7210426Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010534477), received between Jan 6, 2021 and Jun 9, 2021 — classified as 1 injury, 6 malfunctions.

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

• MalfunctionJun 9, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CUFF REPAIR, WHEN PASSING THE SUTURE OF THE ACCU-PASS, IT LOCKED IN THE WHEEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963775 ↗
• MalfunctionJun 9, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CUFF REPAIR, WHEN PASSING THE SUTURE OF THE ACCU-PASS, IT LOCKED IN THE WHEEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963773 ↗
• MalfunctionMay 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE THE ACCU-PASS WOULD NOT PASS THE MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905689 ↗
• MalfunctionMay 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE THE ACCU-PASS WOULD NOT PASS THE MONOFILAMENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905687 ↗
• InjuryMay 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE ACCU-PASS WIRE KEPT GETTING STUCK IN THE ACCU-PASS AND SURGEON COULD NOT DEPLOY THE WIRE FURTHER THAN 1 INCH WHILE IN THE JOINT. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905013 ↗
• MalfunctionJan 6, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE NYLON MONOFILAMENT OF THE ACU-PASS DID NOT ADVANCE. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11128926 ↗
• MalfunctionJan 6, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE NYLON MONOFILAMENT OF THE ACU-PASS DID NOT ADVANCE. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11128912 ↗