PERFECTPASSER OM-8010Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00817470006971), received between Sep 20, 2017 and Jul 29, 2024 — classified as 5 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Material Separation” (56 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TOP JAW OF THE SMARTSTITCH BROKE OFF WHEN ACTIVATED. THE DEVICE BROKE INSIDE THE PATIENT AND THE BROKEN PIECE CAME OUT AND FELL ON THE FLOOR WHEN THE SURGEON WAS REMOVING THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856769 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE JAW OF THE SMARTSTITCH PP CONNECTOR BROKE UPON OPENING. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679866 ↗
• MalfunctionJun 1, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILE PACKET OF A SMARTSTITCH HAD BLACK FLAKES IN IT AND THIS WAS DETECTED AT THE TIME OF OPENING, THE SURGEON AND STAFF WERE NOT HAPPY TO USE IT, THEY OPENED ANOTHER SMITH AND NEPHEW DEVICE OF A DIFFERENT LOT AND PROCEEDED WITH THE CASE. THIS HAPPENED BEFORE A SHOULDER SCOPE: THEREFORE THE DEVICE WAS NOT USED ON A PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917268 ↗
• MalfunctionNov 6, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A MINI OPEN ROTATOR CUFF REPAIR, THE JAW OF THE SMARTSTITCH PERFECT PASSER DID NOT CLOSE PROPERLY NOT ALLOWING THE STITCH CARTRIDGE TO BE PASSED CORRECTLY. I WAS ALSO ATTACHED TO HANDLE AND WAS LOADED WITH SUTURE BUT THE JAWS DID NOT OPEN OR CLOSE PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. A DELAY OF 5-10 MINUTES WERE REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 10805251 ↗
• MalfunctionApr 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE TOP JAW OF THE SMARTSTITCH FELL OFF OF THE CONNECTOR ON TWO SEPARATE CONNECTORS OUTSIDE OF THE JOINT. THE PROCEDURE WAS COMPLETED WITHOUT 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 9966170 ↗
• MalfunctionApr 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, THAT PERFECT PASSER CONNECTOR TOP JAW FELL OFF. WHEN THE DEVICE WAS PULLED OUT OF THE SHOULDER, THE TOP JAW WAS MISSING. MISSING PIECE WAS LOCATED ON THE FLOOR. THE PROCEDURE WAS COMPLETED WITHOUT 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 9966168 ↗
• MalfunctionApr 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE MOVING JAW OF THE SMARTSTITCH BROKE OFF FROM THE CONNECTOR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY (2 MINUTES) USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966151 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE OF SMART STITCH WAS NOT FIRING. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WAS A BACK UP DEVICE AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966095 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE OF SMARTSTITCH WAS NOT FIRING. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WAS A BACK UP DEVICE AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966085 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE OF SMART STITCH WAS NOT FIRING. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WAS A BACK UP DEVICE AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966083 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE PERFECT PASSER JAWS DID NOT CLOSE AFTER INSERTING INTO CUFF. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. A BACK UP DEVICE WAS AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966038 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE PERFECT PASSER JAW WAS NOT OPENING OR CLOSING PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT 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 9966037 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE TOP JAW SNAPPED OFF THE FIRST CONNECTOR OUTSIDE THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966025 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TOP JAW BROKE OFF OUTSIDE THE JOINT DURING THE PROCEDURE. THERE WAS NO FORCE APPLIED TO CAUSE THE BREAKAGE. WHEN THE JAW WAS RELEASED IT POPPED AND WENT ACROSS THE ROOM AND LANDED ON THE FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966014 ↗
• InjuryApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE JAW OF THE SMARTSTITCH BROKE OFF. THE PIECE WAS RETRIEVED. IT IS UNKNOWN IF THERE WAS A DELAY. A BACK-UP WAS AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966005 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, PERFECT PASSER CONNECTION GRASPER BROKE EXTERNAL TO PATIENT. PROCEDURE WAS COMPLETED USING A BACK UP DEVICE AFTER A FIVE MINUTE DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966004 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE UPPER JAW BROKE AFTER SHORT USAGE, WHEN RE-ENTERING THE JOINT THE UPPER JAW FELL ON THE GROUND. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965998 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DR IRELAND WAS USING THE PERFECT PASSER, HE ONLY PASSED ONE SUTURE WHICH WENT THROUGH WITH NO ISSUES, A NEW NEEDLE WAS THEN RELOADED WITHOUT PROBLEM AND AS HE WENT TO PASS HIS SECOND SUTURE HE SAID THE JAW WAS NOT GRASPING THE TISSUE PROPERLY IT APPEARED TO BE LOOSE. HE TOOK IT OUT TO LOOK AT IT AND TRIED AGAIN AND IT WOULDNT GRASP THE TISSUE PROPERLY SO HE ASKED FOR ANOTHER ONE. THE JAW FELT LOOSE AT THE HINGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965976 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE SMART STICH HAD AN OUT OF BOX FAILURE, THE PERFECT PASSER JAW WAS FAULTY. THE PROCEDURE WAS COMPLETED WITHOUT 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 9965883 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT CONNECTOR DIDN'T FIRE WHEN THE HANDPIECE WAS USED. A NEW CONNECTOR WAS OPENED AND IT WORKED FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965787 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE UPPER PART OF THE MOUTH IS BROKEN OFF. BREAKAGE OCCURRED EXTERNAL TO PATIENT. PROCEDURE WAS COMPLETED WITH A S AND N BACK UP DEVICE NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965738 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE UPPER PART OF THE MOUTH IS BROKEN OFF. BREAKAGE OCCURRED EXTERNAL TO PATIENT. PROCEDURE WAS COMPLETED WITH A S AND N BACK UP DEVICE NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965681 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE UPPER PART OF THE MOUTH IS BROKEN OFF. BREAKAGE OCCURRED EXTERNAL TO PATIENT. PROCEDURE WAS COMPLETED WITH A S AND N BACK UP DEVICE NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965572 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PREPARING FOR THE APPLICATION WHILE LOADING THE SUTURE, THE DEVICE FAILED AND THE TIP FELL OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965541 ↗
• MalfunctionApr 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN USING THE PERFECT PASSER WITH SMART STITCH THE END BROKE WHEN IT WAS FIRED. THE PIECE DID NOT COME OFF INSIDE THE PATIENT MR NANDA MANAGED TO REMOVE THE SMART STITCH AND THIS WAS WHEN IT WAS IDENTIFIED THAT THE END HAD BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965392 ↗

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