FIRSTPASS 22-4036Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00817470000184), received between Jun 3, 2018 and Apr 22, 2026 — classified as 8 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break; Difficult to Insert

  IT WAS REPORTED THAT, DURING SET UP FOR A SHOULDER ARTHROSCOPY PROCEDURE, WHEN FITTING THE NEEDLE AND SUTURE CAPTURE INTO THE FIRST PASS SUTURE PASSER, THE BLACK PART DID NOT FIT ALL THE WAY IN BUT WHEN REMOVING THE NEEDLE AND SUTURE CAPTURE, ONLY HALF OF IT WENT IN. THE NEEDLE AND SUTURE CAPTURE WAS NOT FITTING, IT WAS LEFT HALFWAY IN. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH A BIRD BITE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION THE DEVICE WAS FOUND WITH THE NEEDLE FRACTURE OFF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960582 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE NEEDLE AND SUTURE CAPTURE RACK DID NOT LOCK PROPERLY AND CAME LOOSE; IT WAS REMOVED, AND THEY WERE UNABLE TO REATTACH IT. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778172 ↗
• MalfunctionMay 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE FIRSTPASS NEEDLE AND SUTURE CAPTURE WAS IDENTIFIED OF NOT HAVING PASSED A STERILIZATION EFFICACY TEST, AND IT IS UNKNOWN THE NUMBER OF PATIENTS HAVE ALLEGEDLY BEEN DIAGNOSED WITH INFECTIONS DUE TO THE TRAYS CONTAINING THE FIRSTPASS. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 22047985 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S LEFT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A NEEDLE AND SUTURE CAPTURE WAS USED IN THE PROCEDURE. IT IS UNKNOWN IF THE DEVICE WAS RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20251810 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHEN PASSING THE SUTURE OF THE NEEDLE AND SUTURE CAPTURE, THE STITCH BECAME DISLODGED AND THE TOOTH PLATE FELL OFF. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153211 ↗
• MalfunctionAug 9, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, WHEN THE SUTURE WAS PASSED THROUGH THE FORCEPS, IT DID NOT GO THROUGH THE TISSUE. AFTER CHECKING THE DEVICE IT WAS DETERMINED THAT THE TIP OF THE NEEDLE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950608 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE TIP OF THE NEEDLE AND SUTURE CAPTURE CARRYING THE THREAD BROKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715201 ↗
• MalfunctionJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE RACK OF THE FIRSTPASS NEEDLE AND SUTURE CAPTURE DID NOT HOLD THE WIRE, AFTER THE SHOT, IT CAME LOOSE FROM THE RACK. SURGERY WAS COMPLETED WITH BACK-UP DEVICES INSTEAD. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464985 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE NEEDLE AND SUTURE CAPTURE WAS FOUND TO HAVE A BROKEN TIP ONCE IT WAS OPENED AND CLOSED. THE PROCEDURE WAS SUCCESSFULLY 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 18455318 ↗
• MalfunctionDec 5, 2023Break; Component Missing; Detachment of Device or Device Component; Break; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, DURING THE ASSEMBLY OF THE FIRSTPASS NEEDLE TO THE CLAMP, IT WAS OBSERVED THAT THE PLATE (STEP 1) WAS DISASSEMBLED FROM THE ATTACHMENT AND WAS MISSING THE ASSEMBLY HOOK AT THE TIP. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT WAS FOUND THAT THE HOOK ON THE TIP HAS BEEN BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267461 ↗
• InjuryNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE FIRSTPASS NEEDLE AND SUTURE CAPTURE'S PLATE CAME OFF THE FORCEPS IN THE ATTEMPT OF THE FOURTH STITCH. THE SURGICAL TEAM LOOKED FOR IT BUT IT COULD HAVE REMAINED INSIDE THE PATIENT. TO FOLLOW UP, THE DOCTOR SENT CONTROL X-RAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18111796 ↗
• InjuryApr 5, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AN ATTEMPT WAS MADE TO TAKE TISSUE TO PASS THE SUTURE AND PERFORM FIXATION, BUT THE CLAMP OF THE SUTURE CAPTURE DID NOT CLOSE AND BROKE, AND WHEN IT WAS REMOVED, THE MANDIBLE DID NOT RECOVER THE THREAD, IT WAS PROCEEDED TO PERFORM STEPS WITH PENETRATING FORCEPS TO FINISH THE PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683706 ↗
• MalfunctionFeb 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A SHOULDER ARTHROSCOPY SURGERY, A 4.0MM DIAMETER NAIL 4.0MMX36CM FORMERLY ENDER WAS IDENTIFIED WITH THE MESH ALREADY BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502068 ↗
• InjuryJan 21, 2022Break; Break

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF ARTHROSCOPY PROCEDURE, THE SPECIALIST WAS PASSING A SUTURE THROUGH THE PROPERLY MOUNTED FIRST-PASS. AT THE MOMENT OF PASSING THE POINT, THE CLAMP OF THE NEEDLE AND SUTURE CAPTURE FAILED AND FRACTURED IN ITS UPPER PART. ALL THE BROKEN PIECES THAT WERE INSIDE THE PATIENT WERE REMOVED AND A S+N BACK UP PRODUCT WAS USED TO FINISH THE PROCEDURE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314422 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY SETUP, THE NEEDLE AND SUTURE CAPTURE BROKE DURING THE INSTALLATION INTO THE FIRSTPASS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. NO DELAY. AS THIS FAILURE OCCURRED DURING SETUP, THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787962 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, EXTERNAL TO THE PATIENT, THE NEEDLE AND SUTURE CAPTURE IT WAS ASSEMBLED WITH DIFFICULTY AND IT WAS EVIDENT THAT THE TIE PART OF THE PLATE WITH THE CLAMP WAS BROKEN, THEREFORE T WAS NOT ALLOWED TO BE PLACED IN THE FORCEPS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505220 ↗
• MalfunctionJun 18, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, WITH THE NEEDLE AND SUTURE CAPTURE, THE FIRST PASS CLAMP WORKED WELL, HOWEVER THERE WERE PROBLEMS WHEN PASSING AND RETRIEVING THE THREAD, IT WAS PULLED HARD AND THE NEEDLE GOT CAUGHT IN THE CLAMP. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026683 ↗
• MalfunctionApr 28, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE CLAMP OF THE NEEDLE AND SUTURE CAPTURE DEVICE WAS MOUNTED, THE SUTURE POINT WAS PASSED THROUGH THE SUPRA-SPINAL BUT THE SUTURE PLATE ON THE OTHER SIDE OF THE TISSUE WAS NOT GRIPPING, SO THE SUTURE PASSED BUT THE DEVICE WAS NO CAPTURING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACKUP DEVICE. NO PATIENT INJURY OR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11737058 ↗
• MalfunctionMar 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, USING A NEEDLE AND SUTURE CAPTURE, IT WAS PASSED THE SUTURE POINT THROUGH THE SUPRA-SPINAL AND THE BLADE THAT RECOVERED THE SUTURE TO THE OTHER SIDE OF THE FABRIC DID NOT TRAP THE THREADS, IT HAPPENED. IT DID NOT WORK TO CAPTURE IT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548066 ↗
• MalfunctionDec 30, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE FIRST PASS IMPLANT FAILED AND DID NOT ANCHOR TO THE CLAMP, THE SUTURE WAS NOT BEING CAPTURE AND IT WAS IMPOSSIBLE TO HANDLE THE SUTURE AT EASE AND CARRY WITH THE REPAIR. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097793 ↗
• InjuryJun 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE NEEDLE AND SUTURE CAPTURE CRACKED AND THE JAW COULD NOT OPEN, CAUSING THE DEVICE TO NOT CATCH THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 10123135 ↗
• InjuryJun 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE NEEDLE AND SUTURE CAPTURE CRACKED AND THE JAW COULD NOT OPEN, CAUSING THE DEVICE TO NOT CATCH THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 10121682 ↗
• InjuryJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE NEEDLE AND SUTURE CAPTURE HAD THE TIP BROKEN AND COULD NOT OPEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10113109 ↗
• MalfunctionOct 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY UPON THE FIRST USE OF THIS PASSER THE SUTURE CAPTURE TRAP CAME LOOSE AND WAS LEFT WITHIN THE PATIENT ATTACHED TO THE TAPE THAT IT WAS PASSING. AN ARTHROSCOPIC GRASPER WAS USED TO RETRIEVE THE LOOSE MATERIAL FROM THE SHOULDER. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9195098 ↗
• MalfunctionSep 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY FIRSTPASS LOADED, AND THE PASS WAS NOT CONNECT AND BROKE INTO THE PATIENT, PIECES WERE REMOVED FROM PATIENT. A DELAY OF MORE THAN 30 MINUTES HAPPENED. BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9079608 ↗