SMARTSTITCH PERFECTPASSER OM-8176Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470005820), received between Nov 23, 2018 and Nov 3, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A BANKART INTERVENTION WAS SCHEDULED FOR A PATIENT WITH INSTABILITY OF THE LEFT SHOULDER. THE PATIENT WAS ASLEEP, AND THE PROCEDURE STARTED. IT WAS THEN REPORTED THAT THE SURGEON REALIZED THAT THE SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE FOR THE INDOOR LOAN WAS NOT THE RIGHT ONE. THE SURGEON DECIDED TO STOP THE PROCEDURE. LATER, ON THURSDAY 10/10, THE SALES REPRESENTATIVE WAS IN THE OPERATING ROOM TO OPERATE THE PATIENT AGAIN WITH THE CORRECT DEVICE. THE INTERVENTION WAS COMPLETED SUCCESSFULLY AND THE INSTABILITY WAS CORRECTED. IT WAS REPORTED LESS THAN 2 HOURS DELAY AND NO BACK UP WAS AVAILABLE IN THE FIRST SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9270728 ↗
• MalfunctionNov 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BANKART INTERVENTION A PATIENT WITH INSTABILITY OF THE LEFT SHOULDER WAS SCHEDULED TO BE INTERVENED WITH A SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE EQUIPMENT HAD BEEN MADE BY THE HOSPITAL. ONCE THE PATIENT WAS ASLEEP, AND THE PROCEDURE STARTED, IT WAS NOTICED BY THE SURGEON THAT THE SUTURE CARTRIDGE WAS NOT THE RIGHT ONE. THE SURGEON DECIDED TO STOP THE PROCEDURE. DUE TO THIS CANCELLATION IT WAS NOT REPORTED ANY INJURY OR DAMAGE TO PATIENT. SAME PROCEDURE WITH THE CORRECT CARTRIDGE WAS SCHEDULED SIX DAYS LATER AND IT WAS SUCCESSFULLY COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9270727 ↗
• MalfunctionNov 23, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE SMARTSTITCH SUTURE CARTRIDGE BROKE OFF WITH NO OBVIOUS PRESSURE TO CAUSE SAME. THE SURGEON WAS UNABLE TO FIND THE TIP AND THE CONCERN WAS THAT IT COULD BE IN THE PATIENT JOINT. THEY WASHED THE JOINT IN AN EFFORT TO REDUCE THAT RISK WHICH CAUSED A 15 MIN DELAY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8099944 ↗

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