SPECTRUM AUTOPASS SMI-02NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854045756), received between Mar 3, 2017 and Mar 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE SMI-02N, SPECTRUM AUTOPASS SUTURE PASSER NEEDLE DEVICE WAS USED IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026, AND ¿THE NEEDLE BECAME JAMMED AND BROKE INSIDE THE PATIENT.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT FOUND ¿THE NEEDLE FRAGMENTED INSIDE THE PATIENT, BUT THE FRAGMENTS WERE REMOVED USING HOSPITAL INSTRUMENTS.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638964 ↗
• MalfunctionDec 5, 2017Break; Break

  A CONMED AFFILIATE REPORTED ON BEHALF OF A CUSTOMER THAT THE TIP OF THE SMI-02N NEEDLE BROKE OFF DURING PRE-OP TESTING PRIOR TO A ROTATOR CUFF PROCEDURE. THIS ALLEGED MALFUNCTION DID NOT CAUSE HARM TO THE PATIENT OR A SURGICAL DELAY AS IT WAS FOUND BEFORE THE PROCEDURE BEGAN. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAVE NOT BEEN PROVIDED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084681 ↗
• MalfunctionMar 3, 2017Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT WHILE ATTENDING A SHOULDER ARTHROSCOPY PROCEDURE, THE SPECTRUM AUTOPASS SUTURE PASSER AND THE SPECTRUM AUTOPASS NEEDLE WERE USED TO PASS HIFI SUTURE. WHILE PASSING THE SUTURE THE TIP OF THE NEEDLE BROKE OFF INTO THE PATIENT'S SHOULDER. THE TIP WAS RETRIEVED USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A 1-MINUTE DELAY REPORTED AND NO PATIENT INJURY OR ANY FURTHER SURGICAL COMPLICATION. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375951 ↗