FIRSTPASS 22-4035Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00817470000160), received between Aug 13, 2018 and Jun 1, 2026 — classified as 15 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (43 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF, WHEN THE JAW OF THE FORCEPS WAS OPENED, THE JAWBONE DETACHED FROM THE FORCEPS AND WAS RECOVERED. NO PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355780 ↗
• MalfunctionJan 14, 2026Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT FIRST PASS FORCEPS HAD A MISSING "METAL" TIP, WHICH IS PART OF THE FORCEPS ITSELF, SO IT DOESN'T HOLD THE THREAD. THE USER PULLED THE THREAD WITH THE GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067012 ↗
• MalfunctionDec 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE FORCEPS BROKE THE RATCHET'S MOUTH OF THE FIRSTPASS SUTURE PASSER WHILE PASSING THE LAST WIRE OF THE ANCHOR INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME S+N PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744151 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SHOULDER ARTHROSCOPY PROCEDURE, WHILE USING THE FIRSTPASS SUTURE PASSER, THE DOCTOR APPLIED EXCESSIVE FORCE, CAUSING THE INSTRUMENT TO BREAK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638363 ↗
• MalfunctionOct 15, 2025Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE FIRSTPASS DID NOT PASS THE NEEDLE THROUGH THE RACK AND WHEN IT DID, IT DID NOT SECURE THE WIRE. IN ADDITION, A SCREW HOLDING THE DEVICE WAS MISSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294397 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE JAW OF THE FIRSTPASS FRACTURED. NO PART OF THE DEVICE FELL INTO THE PATIENT'S WOUND. 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 22587331 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY, THE NEEDLE OF THE FIRSTPASS SUTURE PASSER WAS BROKEN, PREVENTING PLACEMENT ON THE PIN. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530774 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE FIRSTPASS SUTURE PASSER CLAMP HEAD BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413164 ↗
• MalfunctionJun 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF ARTHROSCOPY, THE JAW OF THE FIRSTPASS SUTURE PASSER BROKE MAKING A BREAKING SOUND, NO PIECES FELL INSIDE THE PATIENT'S WOUND. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22304602 ↗
• MalfunctionJun 1, 2025Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CLAMP OF THE FIRSTPASS WAS NOT HOLDING THE WIRE UNDERNEATH AND APPEARED TO BE LOOSE ON THE RACK AT THE TOP, AS IT DID NOT HAVE THE WIRE. THE SURGERY WAS DELAYED BECAUSE SEVERAL ATTEMPTS HAD TO BE MADE TO PASS IT THROUGH THE CUFF, AND WHEN IT DID PASS THROUGH THE TENDON, THE CLAMP HAD TO BE RETRIEVED USING A GRASPER, AS IT DID NOT HAVE THE WIRE. A 30-MINUTE SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121219 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS EVIDENT THAT THE FIRSTPASS SUTURE PASSER WAS BROKEN AND DID NOT ALLOW THE CORRECT PASSAGE OF THE STITCH IN THE TENDON. NO DAMAGE CAUSED; THE PATIENT'S HEALTH CONDITION IS STABLE. 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 21462285 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FIRSTPASS SUTURE PASSER BROKE DUE TO CONSTANT USE. SURGERY WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129501 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE STITCH WAS BEING PASSED, THE FIRSTPASS SUTURE PASSER BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH THE SAME FAULTY DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039384 ↗
• MalfunctionDec 27, 2024Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE JAW OF THE FIRSTPASS SUTURE PASSER DID NOT CLOSE PROPERLY AND THE NEEDLE WAS LEFT BEHIND, IT COULD NOT BE PULLED OUT SINCE IT WAS HARD. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026140 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN USING THE WIRE THREADER AND INSERTING THE CANULA, AND WHEN THE TRIGGER TO OPEN THE TOOTH. THE FIRST PASS DISSEMBLED AND BROKE A PIECE OF THE TOOTH INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED FROM THE ANATOMY WITH THE HELP OF A KELLY FORCEPS. 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 20833394 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER VIDEO PROCEDURE, WHEN THE SURGEON WAS TRYING TO SEW THE TENDON, THE FIRSTPASS SUTURE PASSER WAS BROKEN, IT WAS VERY THICK. THE SURGEON TRIED TWICE BUT THE NEEDLE WAS COMING OUT ON THE SIDE OF THE PINCER. 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 20825996 ↗
• MalfunctionNov 27, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SHOULDER CUFF ARTHROSCOPY, THE FIRSTPASS SUTURE PASSER GOT STUCK, THE BUTTON THAT UNLOCKS IT WAS PRESSED BUT IT WAS UNABLE, SO IT WAS NOT TAKEN IT OUT OF THE PATIENT. WITH A STRAIGHT KELLY FORCE AND WITH QUITE A LOT OF FORCE THE SURGEON MANAGED TO UNLOCK IT AND THE PRODUCT ENDED UP BREAKING. THE PROCEDURE WAS COMPLETED WITH THE SAME PROCEDURE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797162 ↗
• MalfunctionOct 2, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FIRSTPASS SUTURE PASSER CLAMP BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353027 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE FIRST PASS CLAMP WAS DAMAGED AT THE TIME OF PASSING THE SLEEVE, THE JAW WAS FRACTURED REMAINING INSIDE THE PATIENT, BUT IT WAS POSSIBLE TO BE REMOVE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255953 ↗
• MalfunctionSep 6, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN MOUNTING THE DISPOSABLE PART ON THE FIRSTPASS SUTURE PASSER, IT WAS NOTICED THAT THE TIP OF THE FIRSTPASS SUTURE WAS DAMAGED. IT WAS MOUNTED EVEN SO THAT THE DEVICE COULD BE USED, BUT IT DID NOT BRING THE WIRE, WHEN THE SURGEON USED IT HE DID NOT BRING THE WIRE AND THREW THE FORCEPS. WHEN THE SURGEON GAVE THE STITCH FOR THE SECOND ANCHOR, THE CLAMP WAS LOOSE AND HAD TO BE REMOVED WITH THE GRASPER. A FORCEPS WAS USED FOR THE FIRST ANCHOR AND A PIG'S TAIL FOR THE SECOND ANCHOR. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157171 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, WHEN USING THE FIRSTPASS DEVICE AND THEN REMOVING IT FROM THE PATIENT, THE FORCEPS CAME OUT WITH THE NEEDLE STUCK WITH THE TIP OUTSIDE THE RACK, AND WHEN TRYING TO RETURN IT TO SHAPE, THE RACK BROKE IN HALF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809158 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF SURGERY, THE SURGEON EXPERIENCED DIFFICULTY WHEN USING THE FIRSTPASS SUTURE PASSER, AND ENDED UP BREAKING IT. THE BROKEN PIECES WERE COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, HOWEVER, IT IS UNKNOWN HOW. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691764 ↗
• MalfunctionFeb 9, 2024Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN ASSEMBLING THE CLAMP OF THE FIRSTPASS SUTURE PASSER, THE RACK PART OF IT WAS DAMAGED (NONETHELESS, THE USER WAS ABLE TO ASSEMBLE AND USE IT). ADDITIONALLY, THE WIRE WAS NOT BRINGING, IT WAS PULLED OUT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682345 ↗
• MalfunctionJan 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE NEEDLE ON THE FIRSTPASS SUTURE PASSER WAS NOT COMING OUT SMOOTHLY WHILE TAKING A BITE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510914 ↗
• MalfunctionNov 29, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FIRSTPASS CONSIGNMENT CLAMP WAS FRACTURED, THE MANDIBLE WAS BENT BY MOMENTS INSIDE THE JOINT AND FRACTURED OUTSIDE THE PATIENT. 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 18230016 ↗