SPECTRUM AUTOPASS SMI-02APRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854042243), received between Oct 6, 2017 and Dec 17, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionDec 17, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, SMI-02AP, SPECTRUM AUTOPASS SUTURE PASSER, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6)2024 WHEN IT WAS REPORTED, ¿THE INSTRUMENT BROKE DURING INTRAOPERATIVE CUFF SUTURE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THE PHOTOGRAPHIC EVIDENCE FROM THE REPORTER SHOWS THE BROKEN PIECE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 10-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20950475 ↗
• MalfunctionMay 10, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, SMI-02AP, SPECTRUM AUTOPASS SUTURE PASSER, WAS BEING USED IN EDUCATION SETTING IN THE KNEE OF A CADAVER ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿LOWER JAW BROKE OFF DURING REGULAR USE IN A KNEE CADAVER LAB.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. FOLLOW UP ASSESSMENT QUESTIONING FOUND THAT IT WAS NOT KNOWN IF THE DEVICE FRAGMENTATION WAS REMOVED FROM THE CADAVER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF WHERE THE FRAGMENTATION WAS NOT RETRIEVED. UPDATE: PER THE EVALUATION OF THE DEVICE, NO PARTS WERE MISSING FROM THE DEVICE; THEREFORE, NO FRAGMENTATION COULD REMAIN IN THE CADAVER. THIS REPORT WILL BE UPDATED FROM INJURY TO MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284966 ↗
• MalfunctionMay 10, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, SMI-02AP, SPECTRUM AUTOPASS SUTURE PASSER, WAS BEING USED IN EDUCATION SETTING IN THE KNEE OF A CADAVER ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿LOWER JAW BROKE OFF DURING REGULAR USE IN A KNEE CADAVER LAB.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. FOLLOW UP ASSESSMENT QUESTIONING FOUND THAT IT WAS NOT KNOWN IF THE DEVICE FRAGMENTATION WAS REMOVED FROM THE CADAVER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF WHERE THE FRAGMENTATION WAS NOT RETRIEVED. UPDATE: PER THE EVALUATION OF THE DEVICE, NO PARTS WERE MISSING FROM THE DEVICE; THEREFORE, NO FRAGMENTATION COULD REMAIN IN THE CADAVER. THIS REPORT WILL BE UPDATED FROM INJURY TO MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284964 ↗
• MalfunctionDec 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, WHILE FORCE WAS APPLIED TO THE SMI-02AP SPECTRUM AUTOPASS, THE LOWER JAW SNAPPED. THE LOWER JAW WAS RETRIEVED WITH A GRASPER. AN ALTERNATE INSTRUMENT WAS ALSO UNSUCCESSFUL TO COMPLETE THE PROCEDURE, DUE TO THE THICKNESS AND SCARRING OF THE PATIENT'S CUFF TISSUE. THE SURGEON DECIDED TO MOVE TO A MINI OPEN PROCEDURE DUE TO THE PATIENT'S CONDITION. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE PROCEDURAL DELAY. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS BEING RAISED ON A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126129 ↗
• MalfunctionOct 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A ROTATOR CUFF PROCEDURE THE LOWER JAW OF A SPECTRUM AUTOPASS SUTURE PASSER BROKE WHILE THE DOCTOR TRIED TO PASS THE NEEDLE THROUGH THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPECTRUM DEVICE WITH A REPORTED SURGICAL DELAY OF 20 MINUTES. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6921373 ↗