SMARTSTITCH PERFECTPASSER OM-8175Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470005806), received between May 26, 2019 and Sep 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionSep 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PRIMARY ROTATOR CUFF REPAIR, WHEN THE SURGEON WAS DEPLOYING SUTURE PASSER, THE SUTURE DEPLOYMENT FAILED AND THE PLASTIC TIP OF THE SUTURE CARTRIDGE FELL OFF INTO SHOULDER JOINT. THE SURGEON SPENT TEN MINUTES ATTEMPTING TO RETRIEVE CARTRIDGE TIP, HOWEVER IT WAS THEN LOST INSIDE JOINT AND COULD NOT BE FOUND AGAIN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8952932 ↗
• MalfunctionMay 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, A PERFECT PASSER MAGNUM WIRE SUTURE WAS APPLIED INTO THE TENDON. AFTER THE DEVICE WAS USED IT WAS NOTICED THAT THE END PART OF THE DEVICE WAS BROKEN AND WAS MISSING. THE CONSULTANT HAD A GOOD LOOK AROUND THE SHOULDER JOINT FOR THE BROKEN PIECE BUT COULDN¿T FIND IT WITHIN THE JOINT AND WAS SATISFIED THAT THE BROKEN PIECE WAS NOT IN THE JOINT. THE ISSUE DID NOT CAUSE ANY DELAY IN THE PROCEDURE AND IT WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO ADDITIONAL TREATMENT OR X-RAY WAS CARRIED OUT AT THE TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 8643278 ↗

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