SMARTSTITCH PERFECTPASSER OM-8177Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470001112), received between Feb 6, 2019 and May 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K123268); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2019Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR UPON PASSING THE SUTURE THROUGH THE ROTATOR CUFF THE SUTURE CARTRIDGE SNAPPED. WHEN PULLING OUT, THE SUTURES HAD NOT BEEN PASSED THROUGH. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED. NO PIECES WERE LOST INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628760 ↗
• MalfunctionFeb 6, 2019Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE PERFECT PASSER SUTURE BROKE IN TWO PLACES AFTER PASSING THROUGH CUFF TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313386 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123268. One submission often covers many models, so check the product and lot details in each record.

• Z-3000-2020 · Feb 21, 2019 · Terminated
  Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971